Product Code: BZM FDA class 2 21 CFR 868.1900

Calculator, Pulmonary Function Interpretor (Diagnostic)

Anesthesiology

The Calculator, Pulmonary Function Interpretor (Diagnostic) is a device that interprets pulmonary function test data and provides diagnostic conclusions or categorizations of lung function abnormalities to assist clinicians in clinical decision-making. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BZM, regulated under 21 CFR 868.1900 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: BZM
Device Class: FDA class 2
Regulation Number: 868.1900
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 26 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K102229	PULMOTRACK 2020 SYSTEM	Mar 04, 2011	Substantially Equivalent	Karmelsonix
K090863	PERSONAL WHEEZOMETER	Sep 21, 2009	Substantially Equivalent	Karmelsonix
K071955	WIM-PC, MODEL 1010	Nov 01, 2007	Substantially Equivalent	Karmelsonix
K012387	STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM	Apr 23, 2002	Substantially Equivalent	Stethographics, Inc.
K980878	PULMOTRACK,MODEL 1010	Dec 28, 1998	Substantially Equivalent	Karmel Medical Acoustic Technologies , Ltd.
K974200	ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM	Jul 21, 1998	Substantially Equivalent	Orca Diagnostics Corp.
K955432	CPX, CCM, CATH WITH 15% CO2	Jul 01, 1996	Substantially Equivalent	Medical Graphics Corp.
K923209	MEDGRAPHICS EXERCISE CONSULT	Mar 11, 1993	Substantially Equivalent	Medical Graphics Corp.
K911143	PB100 DIAGNOSTIC SPIROMETER	Nov 29, 1991	Substantially Equivalent	Puritan Bennett Corp.
K896345	EXERCISE EVALUATION SYSTEM 2010	Jan 20, 1990	Substantially Equivalent	Medical Graphics Corp.
K880550	BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS	Jul 25, 1988	Substantially Equivalent	Medimicro Systems, Inc.
K874902	SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY	Jun 07, 1988	Substantially Equivalent	Gomi Medical Instruments
K871711	MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEM	Sep 25, 1987	Substantially Equivalent	Medical Graphics Corp.
K864911	EXERSYSTEM(TM) MMC 5000	Aug 21, 1987	Substantially Equivalent	Med Science
K864885	SPIROVISION	Jan 15, 1987	Substantially Equivalent	Futuremed Div. of Future Impex Corp.
K863953	SPIROMETRICS MODEL 2500 FLOWMATE(TM)	Jan 15, 1987	Substantially Equivalent	Spirometrics, Inc.
K861929	PULMONARY FUNCTION TEST LABORATORY, SYSTEM 1070	Sep 26, 1986	Substantially Equivalent for Some Indications	Medical Graphics Corp.
K853190	SUPERSPIRO	Sep 26, 1985	Substantially Equivalent	Cdx Corp.
K851706	UNIVERSAL COMPUTER INTERFACE SYSTEM	May 03, 1985	Substantially Equivalent	Vacumetrics, Inc.
K842782	PHYSIOLOGICAL ANALYZER CM-710	Aug 17, 1984	Substantially Equivalent	Cybermedic, Inc.
K831586	CM-VII PHYSIOLOGIC ANALYZER	Mar 19, 1984	Substantially Equivalent	Cybermedic, Inc.
K820035	CDX 200	Mar 10, 1982	Substantially Equivalent	Cdx Corp.
K801496	PULMONARY LAB AUTOMATION SYSTEM	Jul 21, 1980	Substantially Equivalent	Medical Graphics Corp.
K801495	CARDIO-PULMONARY EXERCISE STRESS SYSTEM	Jul 21, 1980	Substantially Equivalent	Medical Graphics Corp.
K791229	CYBER DX 100	Jul 30, 1979	Substantially Equivalent	Cyber Diagnostics
K771371	SCREENING COMPUTEO SC-20	Aug 04, 1977	Substantially Equivalent	Cavitron Corp.