Product Code: CBQ FDA class 2 21 CFR 868.1500

Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)

Anesthesiology

The Gaseous-Phase Enflurane Anesthetic Concentration Analyzer is an anesthesiology device that measures the concentration of enflurane, a volatile halogenated anesthetic agent, in the gas phase of the breathing circuit during anesthesia delivery, enabling precise control of anesthetic depth. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CBQ, regulated under 21 CFR 868.1500, within the Anesthesiology medical specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: CBQ
Device Class: FDA class 2
Regulation Number: 868.1500
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 22 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K040917	PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B	Apr 29, 2004	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K994188	MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5	May 19, 2000	Substantially Equivalent	Agilent Technologies, GmbH
K962648	OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR	Jan 17, 1997	Substantially Equivalent	Ohmeda Medical
K931439	OHMEDA MODEL 5330 ANESTHETIC MONITOR	Oct 19, 1993	Substantially Equivalent	Ohmeda Medical
K926451	DATASCOPE MULTINEX II	Aug 25, 1993	Substantially Equivalent	Datascope Corp.
K923433	AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE	Jul 22, 1993	Substantially Equivalent	Instrumentarium Corp.
K923276	CAPNOMAC ULTIMA ANESTHESIA MONITOR	Jul 21, 1993	Substantially Equivalent	Datex Division Instrumentarium Corp.
K922876	AS/3 COP MODULE	Jul 21, 1993	Substantially Equivalent	Datex Division Instrumentarium Corp.
K930303	DATASCOPE MULTINEX ID PLUS	Jun 16, 1993	Substantially Equivalent	Datascope Corp.
K914295	ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED	Apr 10, 1992	Substantially Equivalent	Bruel & Kjaer
K911644	NGM FRAME	Mar 04, 1992	Substantially Equivalent	Datex Division Instrumentarium Corp.
K911647	NGM GAS MODULE	Sep 19, 1991	Substantially Equivalent	Datex Division Instrumentarium Corp.
K903104	CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR	Jan 23, 1991	Substantially Equivalent	Datex Division Instrumentarium Corp.
K902021	RASCAL II RESPIRATORY AND ANESTHETIC GAS MONITOR	Oct 09, 1990	Substantially Equivalent	Albion Instruments
K892854	ANESTHETIC AGENT MONITOR	Oct 13, 1989	Substantially Equivalent	Criticare Systems, Inc.
K892646	BIOCHEM 8100 ANESTHETIC AGENT MONITOR	Aug 31, 1989	Substantially Equivalent	Biochem International, Inc.
K890606	OHMEDA 5330 AGENT MONITOR	Apr 20, 1989	Substantially Equivalent	Ohmeda Medical
K883532	ICOR AGENT MONITOR	Nov 04, 1988	Substantially Equivalent	Icor AB
K881264	PERMA PURE NAFION TUBE DRYER-MODEL ME	Oct 25, 1988	Substantially Equivalent	Perma Pure Products, Inc.
K863248	PB GRAPHICS PRINTER AND PB VIDEO DISPLAY	Sep 03, 1986	Substantially Equivalent	Datex Division Instrumentarium Corp.
K861397	OHMEDA 5300 ANESTHETIC AGENT MONITOR	May 29, 1986	Substantially Equivalent	Ohmeda Medical
K861474	PB253 TO PB254 IR - SPECTROMETER UPGRADE KIT	May 02, 1986	Substantially Equivalent	Datex Division Instrumentarium Corp.