Product Code: EWO FDA class 2 21 CFR 874.1050

Audiometer

Ear, Nose, Throat

The audiometer is a diagnostic device used by audiologists and clinicians to measure a patient's hearing sensitivity across a range of frequencies and intensities, producing an audiogram that characterizes the type and degree of hearing loss. It is classified as FDA Class 2, indicating moderate risk and requiring special controls. The product code is EWO, regulated under 21 CFR 874.1050 in the Ear, Nose, Throat specialty. No implant, life-sustaining, GMP-exempt, or third-party review designations apply.

View on FDA

510(k)s

235

FEI Numbers

Registration Numbers

Unique Applicants

109

Years Active

Basic Information

Product Code: EWO
Device Class: FDA class 2
Regulation Number: 874.1050
Medical Specialty: Ear, Nose, Throat
Review Panel: EN
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 235 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K234095	OtoNova/OtoNova Pro	Jun 21, 2024	Substantially Equivalent	Otodynamics
K240430	Otoport Pro	Mar 15, 2024	Substantially Equivalent	Otodynamics Ltd
K231545	hearOAE	Oct 27, 2023	Substantially Equivalent	hearX SA (Pty) Ltd
K213345	Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE	Jun 22, 2022	Substantially Equivalent	Path Medical GmbH
K191372	Lyra	Jul 15, 2019	Substantially Equivalent	Interacoustics A/S
K180287	GSI Corti	May 11, 2018	Substantially Equivalent	Grason-Stadler Inc.
K173567	Sera	Feb 14, 2018	Substantially Equivalent	Interacoustics A/S
K172403	GSI Novus	Oct 20, 2017	Substantially Equivalent	Grason-Stadler Inc.
K171506	Easyscreen	Aug 29, 2017	Substantially Equivalent	Maico Diagnostics GmbH
K151025	iHearTest	Dec 29, 2015	Substantially Equivalent	IHEAR MEDICAL, INC.
K150491	ER36 Series OAE Test System	Mar 26, 2015	Substantially Equivalent	ETYMOTIC RESEARCH, INC.
K141524	NEURO-AUDIO	Mar 12, 2015	Substantially Equivalent	TELEEMG, LLC USA
K143395	Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit	Feb 23, 2015	Substantially Equivalent	OTODYNAMICS, LTD.
K133012	SENTIERO	Jun 09, 2014	Substantially Equivalent	PATH MEDICAL GMBH
K130795	TITAN	Jun 20, 2013	Substantially Equivalent	INTERACOUSTICS A/S
K123624	OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM	Mar 28, 2013	Substantially Equivalent	MIMOSA ACOUSTICS, INC.
K122496	AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM	Nov 01, 2012	Substantially Equivalent	BIO-LOGIC SYSTEMS CORP.
K121512	SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM	Jul 26, 2012	Substantially Equivalent	BIO-LOGIC SYSTEMS CORP.
K112992	EARLOGIC OAE TESTER	Apr 20, 2012	Substantially Equivalent	EARLOGIC CORPORATION
K112247	A BAER WITH ABAER I/O FUNCTION	Apr 02, 2012	Substantially Equivalent	NATUS MEDICAL INCORPORATED
K111618	AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION	Dec 28, 2011	Substantially Equivalent	NATUS MEDICAL INCORPORATED
K112733	ER35 ERO-SCAN PRO HEARING TEST SYSTEM	Dec 16, 2011	Substantially Equivalent	ETYMOTIC RESEARCH, INC.
K103298	ACAM 5 AUDIOMETER SYSTEM	Apr 08, 2011	Substantially Equivalent	ACOUSTICON GMBH
K092089	CLARUJUST	Mar 10, 2010	Substantially Equivalent	AUDIGENCE, INC.
K092244	MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS	Mar 01, 2010	Substantially Equivalent	DIAGNOSTIC GROUP LLC
K092111	ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204	Oct 02, 2009	Substantially Equivalent	ENTOMED AB
K090406	EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE	Jul 22, 2009	Substantially Equivalent	INTERACOUSTICS AS
K081234	GN OTOMETRICS INSERT EARPHONES	Jul 14, 2008	Substantially Equivalent	GN OTOMETRICS
K072033	OTODYNAMICS OTOPORT	Nov 13, 2007	Substantially Equivalent	OTODYNAMICS, LTD.
K070880	ER35 ERO-SCAN PRO HEARING TEST SYSTEM	Jun 07, 2007	Substantially Equivalent	ETYMOTIC RESEARCH, INC.
K063452	MA 55 MAESTRO	Mar 29, 2007	Substantially Equivalent	MAICO DIAGNOSTICS (DIAGNOSTIC GROUP LLC)
K070118	OTOGRAM, CA3350	Mar 07, 2007	Substantially Equivalent	TYMPANY, INC.
K063338	HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER	Jan 04, 2007	Substantially Equivalent	MIMOSA ACOUSTICS, INC.
K061744	COCHLEA-SCAN / COCHLEA-SCAN PLUS	Sep 15, 2006	Substantially Equivalent	BIO-LOGIC SYSTEMS CORP.
K060883	PILOT TEST OR DETECTIVE AUDIOMETERS	Jun 23, 2006	Substantially Equivalent	INTERACOUSTICS A/S
K060885	MODEL MI 44 TYMPANOMETER	Jun 05, 2006	Substantially Equivalent	MAICO-DIAGNOSTICS
K060539	DPOAE20 , ECLIPSE	May 30, 2006	Substantially Equivalent	INTERACOUSTICS A/S, ASSENS
K053216	HEARID WIDEBAND MIDDLE EAR POWER ANALYZER	Feb 10, 2006	Substantially Equivalent	MIMOSA ACOUSTICS, INC.
K052562	ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.	Dec 23, 2005	Substantially Equivalent	INTERACOUSTICS AS
K043219	AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS	Feb 04, 2005	Substantially Equivalent	INTERACOUSTICS AS
K033108	VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER	Oct 27, 2003	Substantially Equivalent	VIVOSONIC, INC.
K031713	AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS	Aug 12, 2003	Substantially Equivalent	VIASYS HEALTHCARE, INC.
K031986	ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS	Jul 24, 2003	Substantially Equivalent	ICS MEDICAL
K031352	BIO-LOGIC INSERT EARPHONES	Jul 16, 2003	Substantially Equivalent	BIO-LOGIC SYSTEMS CORP.
K030016	TEOAE25	Mar 28, 2003	Substantially Equivalent	INTERACOUSTICS A/S, ASSENS
K024205	AUDIOSCREENER OAE+ABR	Mar 07, 2003	Substantially Equivalent	EVEREST BIOMEDICAL INSTRUMENTS CO.
K023859	SMARTTROAE	Jan 08, 2003	Substantially Equivalent	INTELLIGENT HEARING SYSTEMS
K021801	BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS	Jun 27, 2002	Substantially Equivalent	BIO-LOGIC SYSTEMS CORP.
K011135	GSI AUDERA	Jul 26, 2001	Substantially Equivalent	NICOLET BIOMEDICAL
K003364	VIVO 200 DPS VIVOSCAN	Jul 18, 2001	Substantially Equivalent	VIVOSONIC, INC.
K011114	ETYMOTIC RESEARCH ER-10D OAE PROBE	Jul 03, 2001	Substantially Equivalent	ETYMOTIC RESEARCH
K011181	ICS MEDICAL CHARTR OAE WITH TYMP	Jun 25, 2001	Substantially Equivalent	ICS MEDICAL CORP.
K003913	HINT AUDIOMETER, OR HINT	Mar 16, 2001	Substantially Equivalent	MAICO-DIAGNOSTICS
K010165	ERO SCAN OAE TEST SYSTEM	Mar 12, 2001	Substantially Equivalent	ETYMOTIC RESEARCH
K002200	CAPELLA	Aug 25, 2000	Substantially Equivalent	MADSEN ELECTRONICS, INC.
K001058	AUDIOSCREENER OAE + ABR	Jun 02, 2000	Substantially Equivalent	KEDLY, INC.
K994033	HORTMANN ECHOMASTER OAE ANALYZER	Feb 24, 2000	Substantially Equivalent	HORTMANN AG
K000184	AUDIOSCREENER OAE	Feb 11, 2000	Substantially Equivalent	KEDLY, INC.
K984547	DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS	Mar 19, 1999	Substantially Equivalent	RESOUND CORP.
K983915	AMPLAID A315 AND A319	Jan 29, 1999	Substantially Equivalent	AMPLIFON S.P.A.
K983851	CAPELLA COCHLEAR EMISSIONS ANALYZER	Jan 28, 1999	Substantially Equivalent	MADSEN ELECTRONICS, INC.
K983712	AMPLAID A311 SERIES	Jan 12, 1999	Substantially Equivalent	AMPLIFON S.P.A.
K983352	ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK	Dec 11, 1998	Substantially Equivalent	OTODYNAMICS, LTD.
K983351	ILO292 DP ECHOPORT PLUS OAE SYSTEM	Dec 11, 1998	Substantially Equivalent	OTODYNAMICS, LTD.
K983350	ILO292 DP ECHOPORT PLUS OAE SYSTEM	Dec 11, 1998	Substantially Equivalent	OTODYNAMICS, LTD.
K983048	AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER	Nov 17, 1998	Substantially Equivalent	AMERICAN ELECTROMEDICS CORP.
K982878	EARSCAN 3	Nov 03, 1998	Substantially Equivalent	MICRO AUDIOMETRICS CORP.
K982723	MAICO MA42	Oct 28, 1998	Substantially Equivalent	BERNAFON-MAICO, INC.
K982642	ECHO-SCREEN	Oct 21, 1998	Substantially Equivalent	FISCHER-ZOTH AUDIOLOGIC SYSTEMS, INC.
K982566	AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM)	Oct 21, 1998	Substantially Equivalent	BAR - ADVANCED CONTROL SYSTEMS LTD.
K982441	CCA-220	Oct 09, 1998	Substantially Equivalent	BENSON MEDICAL INSTRUMENTS CO.
K982249	INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER	Aug 07, 1998	Substantially Equivalent	IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE)
K981511	OTO WIZZARD	Jul 24, 1998	Substantially Equivalent	MEDRX, INC.
K981439	CCA-200	Jun 15, 1998	Substantially Equivalent	BENSON MEDICAL INSTRUMENTS CO.
K981460	CUB DIS II DPOAE MEASUREMENT SYSTEM	May 20, 1998	Substantially Equivalent	MIMOSA ACOUSTICS, INC.
K981327	INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER	May 11, 1998	Substantially Equivalent	IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE)
K981142	MAICO MA53	Apr 22, 1998	Substantially Equivalent	BERNAFON-MAICO, INC.
K980505	HORTMANN AMDIS-OAE OAE ANALYZER	Apr 07, 1998	Substantially Equivalent	HORTMANN AG
K980533	ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34)	Mar 23, 1998	Substantially Equivalent	ETYMOTIC RESEARCH
K973377	SIBELMED AC50D	Mar 10, 1998	Substantially Equivalent	TRUTONE
K974237	GSI 70 AUDIOPATH SCREENER	Feb 10, 1998	Substantially Equivalent	GRASON-STADLER, INC.
K974076	SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE	Jan 22, 1998	Substantially Equivalent	BIO-LOGIC SYSTEMS CORP.
K973320	ARTICULATE FITTING SYSTEM	Nov 25, 1997	Substantially Equivalent	DECIBEL INSTRUMENTS, INC.
K972862	AMPLAID 171S	Oct 31, 1997	Substantially Equivalent	AMPLIFON S.P.A.
K972221	K 15 AUDIOMETER	Sep 08, 1997	Substantially Equivalent	AMERICAN ELECTROMEDICS CORP.
K971747	AMPLAID 460	Aug 05, 1997	Substantially Equivalent	AMPLIFON S.P.A.
K971080	MAICO MA52	Jun 06, 1997	Substantially Equivalent	BERNAFON-MAICO, INC.
K964132	MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT	May 13, 1997	Substantially Equivalent	BIO-LOGIC SYSTEMS CORP.
K970279	RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2)	Mar 18, 1997	Substantially Equivalent	AMERICAN ELECTROMEDICS CORP.
K970555	IL0292 DP ECHOPORT	Mar 17, 1997	Substantially Equivalent	SMITH
K964426	SMARTOAE	Feb 03, 1997	Substantially Equivalent	INTELLIGENT HEARING SYSTEMS
K964340	PORTAREM-3000, PFS-6000	Jan 10, 1997	Substantially Equivalent	STARKEY LABORATORIES, INC.
K962995	ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC	Jan 10, 1997	Substantially Equivalent	OTODYNAMICS, LTD.
K963681	CCA-100 (MODIFIED)	Oct 08, 1996	Substantially Equivalent	BENSON MEDICAL INSTRUMENTS CO.
K962275	MAICO MA25 SERIES II WITH SPEECH	Sep 05, 1996	Substantially Equivalent	BERNAFON-MAICO, INC.
K962012	ETHICAL HEARING INSTRUMENTS/WIZARD HEARING PROFILE TESTER	Aug 21, 1996	Substantially Equivalent	ETHICAL HEARING INSTRUMENTS
K961447	SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE) TEST INSTRUMENT	May 29, 1996	Substantially Equivalent	BIO-LOGIC SYSTEMS CORP.
K953814	OTOSCAPE	Dec 21, 1995	Substantially Equivalent	SOUNDSCAPE TECHNOLOGIES, INC.
K953884	PROPHET	Oct 27, 1995	Substantially Equivalent	QUALITONE
K953684	GSI 61 CLINICAL AUDIOMETER	Oct 27, 1995	Substantially Equivalent	GRASON-STADLER, INC.
K943616	BELTONE PERSONAL HEARING SCREENER	Jul 12, 1995	Substantially Equivalent	BELTONE ELECTRONICS CORP.
K951759	GSI 65 COMPUTERIZED AUDIOMETER	Jul 06, 1995	Substantially Equivalent	GRASON-STADLER, INC.
K943215	DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER	May 12, 1995	Substantially Equivalent	KENNETH ULLRICH
K951527	THE PILOT AUDIOMETER	May 03, 1995	Substantially Equivalent	AMERICAN ELECTROMEDICS CORP.
K945199	RH2000 REAL EAR MEASUREMENT SYSTEM	Apr 11, 1995	Substantially Equivalent	MADSEN ELECTRONICS, INC.
K950888	SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY	Mar 21, 1995	Substantially Equivalent	CALMED TECHNOLOGY, INC.
K945689	GAME AUDIOMETERY WORD IDENTIFICATION AUDIOMETRY FOR USE WITH PRODIGIT(TM) 2000 PERSONAL DIGITAL AUDIOMETER(TM)	Feb 08, 1995	Substantially Equivalent	CALMED TECHNOLOGY, INC.
K945032	VOYAGER 522	Feb 02, 1995	Substantially Equivalent	MADSEN ELECTRONICS, INC.
K944735	BIO-LOGIC EMAV EMISSION AVERAGING OTOACOUSTIC TEST	Dec 21, 1994	Substantially Equivalent	BIO-LOGIC SYSTEMS CORP.
K941920	INTERACOUSTICS CLINICAL AUDIOMETER	Sep 16, 1994	Substantially Equivalent	PRECISION ACOUSTICS IND., INC.
K942716	AUDIO EXPERT AUDIOMETER	Sep 02, 1994	Substantially Equivalent	BELTONE ELECTRONICS CORP.
K943066	INTERACOUSTICS COMPUTER AUDIOMETER BA 20	Aug 24, 1994	Substantially Equivalent	PRECISION ACOUSTICS IND., INC.
K931322	KS 5 - CLINICAL AUDIOMETER	Aug 19, 1994	Substantially Equivalent	MAICO HEARING INSTRUMENTS, INC.
K943065	INTERACOUSTICS CLINICAL AUDIOMETER	Aug 17, 1994	Substantially Equivalent	PRECISION ACOUSTICS IND., INC.
K940216	BELTONE SERIES 100 AUDIOMETERS	Jul 29, 1994	Substantially Equivalent	BELTONE ELECTRONICS CORP.
K935719	DAIL A HEARING SCREENING TEST	Jul 07, 1994	Substantially Equivalent	OCCUPATIONAL HEARING SERVICES
K942006	INTERACOUSTICS DIAGNOSTIC AUDIOMETER	Jun 20, 1994	Substantially Equivalent	PRECISION ACOUSTICS IND., INC.
K934715	MODEL 222 CLINICAL AUDIOMETER	May 10, 1994	Substantially Equivalent	VIRTUAL CORP.
K940999	PRODIGIT 2000	Apr 22, 1994	Substantially Equivalent	CALMED TECHNOLOGY, INC.
K931325	OTOACOUSTIC EMISSIONS UNIT CELESTA 503	Feb 18, 1994	Substantially Equivalent	MADSEN ELECTRONICS (CANADA) LTD.
K935348	ODYSSEY CLINICAL AUDIOMETER	Feb 09, 1994	Substantially Equivalent	QUALITONE
K934658	GSI 60 DPOAE SYSTEM	Feb 01, 1994	Substantially Equivalent	LUCAS GRASON-STADLER, INC.
K933097	SOUND SELECTOR FULL-SERVICE AUDIOMETER	Jan 24, 1994	Substantially Equivalent	ENSONIQ CORP.
K934343	GLASER RT60, RT80, RT150 AUDIOMETER	Jan 21, 1994	Substantially Equivalent	GLASER INSTRUMENTS AG
K933220	SELECTOR SL 01	Nov 24, 1993	Substantially Equivalent	FUTUREMED DIV. OF FUTURE IMPEX CORP.
K931324	ORBITER 922 CLINICAL AUDIOMETER	Nov 19, 1993	Substantially Equivalent	MADSEN ELECTRONICS (CANADA) LTD.
K933222	AUDIOMETER DA 323	Nov 01, 1993	Substantially Equivalent	FUTUREMED DIV. OF FUTURE IMPEX CORP.
K930553	CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT	Sep 29, 1993	Substantially Equivalent	ETYMOTIC RESEARCH
K930112	MAICO MA790 AUDIOMETER	Aug 05, 1993	Substantially Equivalent	MAICO HEARING INSTRUMENTS, INC.
K926439	MA25 - PORTABLE AUDIOMETER, MODIFICATION	Aug 05, 1993	Substantially Equivalent	MAICO HEARING INSTRUMENTS, INC.
K930260	ACOUSTIC ANALYZER AA30	Jul 13, 1993	Substantially Equivalent	PRECISION ACOUSTICS IND., INC.
K930003	TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES	Jun 18, 1993	Substantially Equivalent	ETYMOTIC RESEARCH
K926336	AUDIOSCAN	Mar 04, 1993	Substantially Equivalent	ELECTROCAINE MEDICAL SYSTEM
K924543	DSP SCREENING AUDIOMETER	Feb 26, 1993	Substantially Equivalent	MICRO AUDIOMETRICS CORP.
K923007	AT-2	Feb 26, 1993	Substantially Equivalent	QUALITONE
K922383	THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO	Jan 15, 1993	Substantially Equivalent	MONITOR INSTRUMENTS, INC.
K922746	ST 20 PORTABLE AUDIOMETER	Nov 05, 1992	Substantially Equivalent	MAICO HEARING INSTRUMENTS, INC.
K923074	DANPLEX SCREENING AUDIOMETER	Sep 23, 1992	Substantially Equivalent	LIFE-TECH INTL., INC.
K923013	ACOUSTIC APPRAISE CD-3	Aug 14, 1992	Substantially Equivalent	QUALITONE
K921085	PROGRAMMED AUDIOMETRIC DEVICE (PAD)/RECORS (PAR)	May 15, 1992	Substantially Equivalent	HEAR-WELL TECHNOLOGIES, INC.
K915323	THE BELTONE AUDIO SCOUT	May 11, 1992	Substantially Equivalent	BELTONE ELECTRONICS CORP.
K914232	ASRA, SCREENING AUDIOMETER	Jan 31, 1992	Substantially Equivalent	MERCURY ELECTRONICS (SCOT) LTD.
K913356	THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER	Dec 05, 1991	Substantially Equivalent	MONITOR INSTRUMENTS, INC.
K913589	EARSCAN DSP-1 PURE TONE AUDIOMETER	Nov 05, 1991	Substantially Equivalent	MICRO AUDIOMETRICS CORP.
K913276	MICROTEK MEDICAL'S SOUND STIKS	Oct 21, 1991	Substantially Equivalent	MICROBIO-MEDICS, INC.
K911689	MODEL 330 SCREENING AUDIOMETER	Oct 21, 1991	Substantially Equivalent	VIRTUAL CORP.
K913221	TYPE FA10 AUDIOMETER	Oct 11, 1991	Substantially Equivalent	FRYE ELECTRONICS, INC.
K904622	HEARING CHECKER(TM), DESKTOP MODEL	Sep 17, 1991	Substantially Equivalent	QUALITONE HEARING AIDS AND AUDIOMETERS
K912669	RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM	Sep 16, 1991	Substantially Equivalent	RESOUND CORP.
K911368	MAICO MA800 AUDIOMETER	Jun 26, 1991	Substantially Equivalent	MAICO HEARING INSTRUMENTS, INC.
K900197	THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER	Apr 17, 1991	Substantially Equivalent	SOUND LINKED DATA, INC.
K904544	ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID	Oct 31, 1990	Substantially Equivalent	QUALITONE
K904270	BIOLINK AUDIOMETER SOFTWARE ACCESSORY	Oct 09, 1990	Substantially Equivalent	MICRO AUDIOMETRICS CORP.
K903143	OTOSCREENER-I AND OTO-SCREEN-I-P	Sep 19, 1990	Substantially Equivalent	HANDTRONIX, INC.
K902068	HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER	Aug 06, 1990	Substantially Equivalent	STARKEY LABORATORIES, INC.
K902540	GSI 17 SCREENING AUDIOMETER	Jul 13, 1990	Substantially Equivalent	GRASON-STADLER, INC.
K894484	AUDIOTESTER SCREENING AUDIOMETER	Jun 26, 1990	Substantially Equivalent	PROMETEX, INC.
K900096	INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA)	May 31, 1990	Substantially Equivalent	ARTIFICAL HEARING SYSTEMS CORP.
K896710	MIDIMATE 622	Apr 13, 1990	Substantially Equivalent	MADSEN NORTH AMERICA, INC.
K896401	MICROMATE 304	Mar 27, 1990	Substantially Equivalent	MADSEN NORTH AMERICA, INC.
K896909	MD5 AUTOMATIC AUDIOMETER	Mar 05, 1990	Substantially Equivalent	SINGER MEDICAL PRODUCTS, INC.
K895310	AUDIOMETER/MASTER HEARING AID, MAICO MODEL MF7	Jan 23, 1990	Substantially Equivalent	MAICO HEARING INSTRUMENTS, INC.
K895200	MODEL EB-22 NOISE STIK	Jan 22, 1990	Substantially Equivalent	ECKSTEIN BROTHERS, INC.
K895785	AUDIOMETER MODEL MD-4, MD-4P	Dec 05, 1989	Substantially Equivalent	SINGER MEDICAL PRODUCTS, INC.
K895784	IMPEDANCE ANALYZER/AUDIOMETER MODEL MD-3	Dec 05, 1989	Substantially Equivalent	SINGER MEDICAL PRODUCTS, INC.
K894748	IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P	Dec 05, 1989	Substantially Equivalent	SINGER MEDICAL PRODUCTS, INC.
K891988	AMPLAID A308 CLINICAL AUDIOMETER	Oct 12, 1989	Substantially Equivalent	AMPLUS CORP.
K890993	AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID	Oct 12, 1989	Substantially Equivalent	MAICO HEARING INSTRUMENTS, INC.
K883505	BIOMETER AUDIOMETER	Aug 21, 1989	Substantially Equivalent	MICRO AUDIOMETRICS CORP.
K891373	TRACOR RA500 AUDIOMETER	Jul 14, 1989	Substantially Equivalent	TRACOR INSTRUMENTS AUSTIN, INC.
K890124	ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER	Jul 14, 1989	Substantially Equivalent	GRASON-STADLER, INC.
K890842	2400 AUDIOMETER, IMPEDANCE METER & HRNG. AID ANALY	Jun 07, 1989	Substantially Equivalent	MAICO HEARING INSTRUMENTS, INC.
K890497	MODEL 20-P EXTENDED HIGH FREQUENCY AUDIOMETER	Jun 06, 1989	Substantially Equivalent	MONITOR/DEMLAR
K884218	AUDIOSCOPE 3 MODEL 23300 ACCESSORIES	Mar 10, 1989	Substantially Equivalent	WELCH ALLYN, INC.
K884044	AUDIOMETER DIGITAL HEARING SYSTEM	Feb 22, 1989	Substantially Equivalent	RESOUND CORP.
K883169	OTOMETER PORTABLE SCREENING AUDIOMETER	Dec 07, 1988	Substantially Equivalent	OTOMETER, INC.
K883478	DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602	Nov 17, 1988	Substantially Equivalent	MADSEN ELECTRONICS (CANADA) LTD.
K881760	AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER	Jun 10, 1988	Substantially Equivalent	AMERICAN ELECTROMEDICS CORP.
K880059	AMPLAID 309 CLINICAL AUDIOMETER	Feb 23, 1988	Substantially Equivalent	AMPLUS CORP.
K875360	THE BELTONE 2000 AUDIOMETER	Feb 17, 1988	Substantially Equivalent	BELTONE ELECTRONICS CORP.
K874516	MODEL V4 AUDIOMETER	Dec 14, 1987	Substantially Equivalent	DIGITAL HEARING SYSTEMS CORP.
K872042	PLAYTONE AUDIOMETER	Aug 11, 1987	Substantially Equivalent	SENSORY AIDS CORP.
K863984	MODEL 320 TWO CHANNEL AUDIOMETER	Nov 18, 1986	Substantially Equivalent	VIRTUAL CORP.
K863979	MICROSCREEN I HEARING TESTER	Nov 18, 1986	Substantially Equivalent	MICROSCREEN
K862592	PHOENIX SYSTEM SEVEN.	Sep 16, 1986	Substantially Equivalent	NICOLET BIOMEDICAL INSTRUMENTS
K862770	AUDIOMETER/MASTER HEARING AID MF6	Aug 15, 1986	Substantially Equivalent	MAICO HEARING INSTRUMENTS, INC.
K854835	DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER	Mar 04, 1986	Substantially Equivalent	MIRACLE-EAR/DAHLBERG, INC.
K854534	DIGITAL SCREENING AUDIOMETER DSA6214	Feb 13, 1986	Substantially Equivalent	MADSEN ELECTRONICS (CANADA) LTD.
K854125	CRAIGWELL AID FITTING SYSTEM AFS	Jan 16, 1986	Substantially Equivalent	CRAIGWELL ELECTRONICS, LTD.
K853919	MA25 PORTABLE AUDIOMETER	Dec 18, 1985	Substantially Equivalent	MAICO HEARING INSTRUMENTS, INC.
K853245	TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETER	Oct 16, 1985	Substantially Equivalent	TRACOR INSTRUMENTS, INC.
K851392	TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200	Jun 20, 1985	Substantially Equivalent	TRACOR INSTRUMENTS, INC.
K851015	TA-20 AUTOMATIC INDUSTIRAL AUDIOMETER	Jun 04, 1985	Substantially Equivalent	TELEDYNE AVIONICS DIV. OF TELEDYNE
K845050	UP800 A UNIVERSAL PRINTER	May 29, 1985	Substantially Equivalent	MADSEN ELECTRONICS (CANADA) LTD.
K844069	TA-201 CLINICAL AUDIOMETER	Dec 03, 1984	Substantially Equivalent	TELEDYNE AVIONICS DIV. OF TELEDYNE
K843618	AUDIOMETER	Dec 03, 1984	Substantially Equivalent	GRASON-STADLER, INC.
K841567	AUDIOMETER MA728	Jun 27, 1984	Substantially Equivalent	MAICO HEARING INSTRUMENTS, INC.
K841167	DEMLAR SYS I COMPUTER BASED AUDIOMETER	Jun 27, 1984	Substantially Equivalent	DEMLAR MEDICAL, INC.
K833883	DIGITAL AUDIOMETER/HEARING AID 3100	Feb 21, 1984	Substantially Equivalent	FRYE ELECTRONICS, INC.
K831431	AUDIOMETER MODEL-500	Jun 30, 1983	Substantially Equivalent	AUDIMAX
K822335	AUDIT	Feb 07, 1983	Substantially Equivalent	AXONICS, INC.
K823554	ACOH WELLNESS TESTER	Jan 05, 1983	Substantially Equivalent	OCCUPATIONAL HEALTH, INC.
K822745	THE SCREENING TYMPANOMETER	Sep 30, 1982	Substantially Equivalent	AMERICAN ELECTROMEDICS CORP.
K822414	TRACOR RA400 AUDIOMETER	Aug 30, 1982	Substantially Equivalent	TRACOR INSTRUMENTS, INC.
K820715	MIDDLE EAR ANALYZER (IMPEDANCE AUDIO	Apr 09, 1982	Substantially Equivalent	GRASON-STADLER, INC.
K812529	EARSCAN	Oct 14, 1981	Substantially Equivalent	MICRO AUDIOMETRICS CORP.
K811727	PORTABLE AUDIOMETERS	Jul 15, 1981	Substantially Equivalent	MAICO HEARING INSTRUMENTS, INC.
K810583	AUDIOMETER	Apr 29, 1981	Substantially Equivalent	GRASON-STADLER, INC.
K810537	AUTOMATIC SCREENING AUDIOMETER	Mar 11, 1981	Substantially Equivalent	POSITRON
K803072	HIGH FREQUENCY AUDIOMETER DELMAR #20-K	Dec 30, 1980	Substantially Equivalent	DEMLAR MEDICAL, INC.
K802963	101, 151, 161 PORTABLE AUDIOMETERS	Dec 19, 1980	Substantially Equivalent	AMPLAID USA, INC.
K802560	TINNITUS RESEARCH AUDIOMETER	Nov 12, 1980	Substantially Equivalent	STARKEY LABORATORIES, INC.
K802350	ATTENU-CHEK	Oct 23, 1980	Substantially Equivalent	HEAR CO., INC.
K802207	RION DIAGNOSTIC AUDIOMETER	Sep 26, 1980	Substantially Equivalent	RION ACOUSTIC INSTRUMENTS, INC.
K801325	CLINICAL AUDIOMETER MODEL TA-200	Jun 30, 1980	Substantially Equivalent	TELEDYNE AVIONICS DIV. OF TELEDYNE
K791467	TA-10 PORTABLE SCREENING AUDIOMETER	Sep 28, 1979	Substantially Equivalent	TELEDYNE AVIONICS DIV. OF TELEDYNE
K790878	SCREENING AUDIOMETER, HIGH FREQUENCY	Aug 03, 1979	Substantially Equivalent	VICON INSTRUMENT CO.
K791170	MIS AURAL ACOUSTIC SCREENER	Jun 25, 1979	Unknown	MAICO HEARING INSTRUMENTS, INC.
K790903	TRACOR MODEL RA-411 MICROPROCESSOR	May 31, 1979	Substantially Equivalent	TRACOR INSTRUMENTS, INC.
K790846	MIDDLE EAR ANALYZER (IMPED. AUDIOMTR)	May 17, 1979	Substantially Equivalent	GRASON-STADLER, INC.
K790609	AUDIOMETER	Apr 10, 1979	Substantially Equivalent	GRASON-STADLER, INC.
K781474	PREAMPLIFIER MODELS 8101PI & 8102PI	Sep 07, 1978	Substantially Equivalent	LIFE-TECH INSTRUMENTS, INC.
K780749	SPEECH AUDIOMETER RA 226	May 16, 1978	Substantially Equivalent	TRACOR INSTRUMENTS, INC.
K780450	TRACOR RA 410 AUDIOMETER	Mar 30, 1978	Substantially Equivalent	TRACOR INSTRUMENTS, INC.
K780382	AUDIOMETER, PORTABLE, AIR CONDUCTION	Mar 14, 1978	Substantially Equivalent	MAICO HEARING INSTRUMENTS, INC.
K780270	COMPUTER AUDIOMETER - MA26	Feb 27, 1978	Substantially Equivalent	MAICO HEARING INSTRUMENTS, INC.
K780269	COMPUTER AUDIOMETER - MA25	Feb 27, 1978	Substantially Equivalent	MAICO HEARING INSTRUMENTS, INC.
K780150	NEONATAL SCREENING AUDIOMETER	Feb 13, 1978	Substantially Equivalent	TELEDIAGNOSTIC SYSTEMS, INC.
K772169	AUDIOMETER, RECORDING, AUTOMATIC	Dec 02, 1977	Substantially Equivalent	B&K INSTRUMENTS, INC.
K770823	AUDIOMETRIC TESTING SYS., SERIES 500	May 18, 1977	Substantially Equivalent	AUTOMATED TESTING SERVICES, LTD.
K770618	AUDIOMETER, MA31	Apr 08, 1977	Substantially Equivalent	MAICO HEARING INSTRUMENTS, INC.
K770616	AUDIOMETER, MA29, PURE TONE AIR CONDUCT.	Apr 08, 1977	Substantially Equivalent	MAICO HEARING INSTRUMENTS, INC.
K770617	AUDIOMETER, MA30, AIR & BONE CONDUCTION	Apr 07, 1977	Substantially Equivalent	MAICO HEARING INSTRUMENTS, INC.
K770553	AUDIOMETER, DIAG., ADVANCED, MA-22	Mar 24, 1977	Substantially Equivalent	MAICO HEARING INSTRUMENTS, INC.
K760859	TRACOR MODEL RA 208 COMPLIANCE AUDIOM	Oct 29, 1976	Substantially Equivalent	TRACOR INSTRUMENTS, INC.

FEI Numbers

This FDA classification entry is associated with 61 FEI numbers. Click on an entry to view related FDA registrations.

1000113738: 17 registrations

1000307595: 3 registrations

1220135: 1 registration

1316463: 77 registrations

1450042: 7 registrations

2011951: 1 registration

2113281: 31 registrations

2939: 4 registrations

3000254565: 46 registrations

3000279201: 26 registrations

3002504821: 9 registrations

3002806418: 2 registrations

3002807554: 24 registrations

3002809369: 81 registrations

3002816805: 1 registration

3003138182: 4 registrations

3004046843: 3 registrations

3004052117: 3 registrations

3005019184: 7 registrations

3005053770: 4 registrations

3005581270: 36 registrations

3005785669: 2 registrations

3006418479: 14 registrations

3007307502: 1 registration

3008111228: 9 registrations

3008386587: 3 registrations

3008699634: 9 registrations

3008717264: 40 registrations

3008881376: 5 registrations

3010539401: 5 registrations

3010608097: 4 registrations

3011310592: 63 registrations

3011359729: 3 registrations

3012118649: 4 registrations

3012213704: 7 registrations

3012302888: 33 registrations

3012494290: 762 registrations

3012636179: 178 registrations

3013557562: 654 registrations

3013596041: 3 registrations

3013598036: 1 registration

3014337591: 7 registrations

3014343954: 11 registrations

3014656175: 4 registrations

3015246392: 7 registrations

3015268290: 26 registrations

3017644066: 2 registrations

3019918054: 6 registrations

3020796592: 1 registration

3020869111: 2 registrations

3024082778: 34 registrations

3026043043: 1 registration

3027357482: 1 registration

3029060079: 1 registration

3030089857: 3 registrations

3030447506: 78 registrations

3030896102: 1 registration

3031700059: 38 registrations

3032948523: 2 registrations

3033482506: 1 registration

3034279033: 1 registration