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FDA 510(k)

BEAR JET 150 VENTILATOR

K-Number: K830165 · 1983-04-12

ApplicantBear Medical Systems, Inc.
Decision Date1983-04-12
Product CodeFLI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BEAR JET 150 VENTILATOR 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 1983-04-12 under 510(k) number K830165. The device is classified under product code FLI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEAR JET 150 VENTILATOR?

BEAR JET 150 VENTILATOR is a medical device that received FDA 510(k) clearance on 1983-04-12. The listed applicant is Bear Medical Systems, Inc.. The 510(k) number is K830165.

When did BEAR JET 150 VENTILATOR receive FDA 510(k) clearance?

BEAR JET 150 VENTILATOR received FDA 510(k) clearance on 1983-04-12, under 510(k) number K830165.

Who is the listed applicant for BEAR JET 150 VENTILATOR?

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 BEAR JET 150 VENTILATOR?

The FDA product code for BEAR JET 150 VENTILATOR is FLI.

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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

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Related Devices (Code: FLI)

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.

K904921STERI-VAC(TM) AERATOR MODEL XL3M Health Care, Ltd.K902906GAS-VAK(R) COMBINATION STERILIZER & VENTILATORGas-VakK831595CASTLE MODEL 3341 & 3441 & 4141 GAS AERCastle Co.K813201CASTLE #3241 GAS AERATORSybron Corp.K790677EO EVACUATING SYSTEM ICastle Co.K781484CASTLE MODEL 3146 GAS AERATORCastle Co.

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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