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FDA 510(k)

GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER

K-Number: K001409 · 2000-08-02

ApplicantHyperbaric Technologies, Inc.
Decision Date2000-08-02
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER is the device name listed in this FDA 510(k) record. The listed applicant is Hyperbaric Technologies, Inc.. It received FDA 510(k) clearance on 2000-08-02 under 510(k) number K001409. The device is classified under product code CBF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER?

GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER is a medical device that received FDA 510(k) clearance on 2000-08-02. The listed applicant is Hyperbaric Technologies, Inc.. The 510(k) number is K001409.

When did GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER receive FDA 510(k) clearance?

GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER received FDA 510(k) clearance on 2000-08-02, under 510(k) number K001409.

Who is the listed applicant for GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER?

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

What is the FDA product code for GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER?

The FDA product code for GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER is CBF.

Related Clinical Trials

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Other records listing Hyperbaric Technologies, 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.

K011866OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES

Related Devices (Code: CBF)

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.

K240569FESL FINK Chamber; FEDL FINK Chamber; FETL FINK ChamberFink Engineering Pty, Ltd.K220290Revitalair 430+Us Hyperbaric NetworkK171899Revitalair 430FOxavita SrlK163109OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyOxyheal Medical Systems, Inc.K152223Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control SystemOxyheal Medical Systems, Inc.K102831RSI 4200Reimers Systems, Inc.

Official Source

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

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