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FDA 510(k)

AIR COMPRESSOR

K-Number: K850795 · 1985-05-28

ApplicantBear Medical Systems, Inc.
Decision Date1985-05-28
Product CodeBTI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AIR COMPRESSOR is the device name listed in this FDA 510(k) record. The listed applicant is Bear Medical Systems, Inc.. It received FDA 510(k) clearance on 1985-05-28 under 510(k) number K850795. The device is classified under product code BTI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIR COMPRESSOR?

AIR COMPRESSOR is a medical device that received FDA 510(k) clearance on 1985-05-28. The listed applicant is Bear Medical Systems, Inc.. The 510(k) number is K850795.

When did AIR COMPRESSOR receive FDA 510(k) clearance?

AIR COMPRESSOR received FDA 510(k) clearance on 1985-05-28, under 510(k) number K850795.

Who is the listed applicant for AIR COMPRESSOR?

The FDA 510(k) record lists Bear Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIR COMPRESSOR?

The FDA product code for AIR COMPRESSOR is BTI.

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Other records listing Bear Medical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K992788BEAR CUB 750 PSVK983981BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBEK912619BEAR 7 VENTILATORK900637BEAR CEM CONTROLLERK896315BEAR VH820 DISPOSABLE CHAMBER ASSEMBLYK893034VHS 820 HUMIDIFIER, MODIFICATION

View all 28 devices →

Related Devices (Code: BTI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131881OMBRA TABLE TOP COMPRESSORTrudell Medical Intl.K113338MEDICAL AIR COMPRESSOROricare, Inc.K091871DK50 DSEkom S.R.O.K072634EMG TRITON -COMP,MODEL NCA01-XXX SERIESEmg Technology Co., Ltd.K060781MEDICAL COMPRESSOR, MODELS DK50 D AND DMEkom S.R.O.K051691MINIMATE COMPRESSORPrecision Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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