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FDA 510(k)

BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY

K-Number: K896315 · 1990-01-22

ApplicantBear Medical Systems, Inc.
Decision Date1990-01-22
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY 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 1990-01-22 under 510(k) number K896315. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY?

BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY is a medical device that received FDA 510(k) clearance on 1990-01-22. The listed applicant is Bear Medical Systems, Inc.. The 510(k) number is K896315.

When did BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY receive FDA 510(k) clearance?

BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY received FDA 510(k) clearance on 1990-01-22, under 510(k) number K896315.

Who is the listed applicant for BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY?

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 VH820 DISPOSABLE CHAMBER ASSEMBLY?

The FDA product code for BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY is BTT.

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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 CONTROLLERK893034VHS 820 HUMIDIFIER, MODIFICATIONK890724MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR

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Related Devices (Code: BTT)

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.

K262268Optiflow Oxygen Kit (AA484J)Fisher and Paykel Healthcare LimitedK254078HVT 2.0Vapotherm, Inc.K251448FL-10000U Respiratory HumidifierFlexicare Medical Limited.K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V.K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra SmallMedline Industries, LP

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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