Product Code: BXP FDA class 1 21 CFR 868.2885

Transducer, Gas Flow

Anesthesiology

The Transducer, Gas Flow is a sensor that measures gas flow rate by converting flow into a proportional electrical signal, used in respiratory monitoring equipment, ventilators, and anesthesia systems. It is classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BXP, regulated under 21 CFR 868.2885 in the Anesthesiology specialty.

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510(k)s

FEI Numbers

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Basic Information

Product Code: BXP
Device Class: FDA class 1
Regulation Number: 868.2885
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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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 7 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K936141	UNIPOWER RECHARGEABLE BATTERY PACK	Mar 31, 1994	Substantially Equivalent	Unipower Corp.
K920360	TIMOX OXYGEN TIMER	Aug 03, 1992	Substantially Equivalent	Medical Fittings, Inc.
K832678	PHONATORY FUNCTION ANALYZER PS-77	Mar 07, 1984	Substantially Equivalent	Kells Medical, Inc.
K800087	ULTRASONIC FLOWMETER	Mar 19, 1980	Substantially Equivalent	The Perkin-Elmer Corp.
K781039	OXY-ON DIGITAL OXYGEN TIMER	Aug 31, 1978	Substantially Equivalent	Chambers & Sadler Mfg.
K770424	OXYGEN TWMER, MODEL SST	Mar 16, 1977	Substantially Equivalent	Timeter Instrument Corp.
K761260	ARIZONA OXYGEN TIMER DEVICE	Dec 16, 1976	Substantially Equivalent	The John Bunn Co.