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FDA 510(k)

MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM

K-Number: K950957 · 1995-06-02

ApplicantGulf Coast Hyperbarics, Inc.
Decision Date1995-06-02
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gulf Coast Hyperbarics, Inc.. It received FDA 510(k) clearance on 1995-06-02 under 510(k) number K950957. 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 MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM?

MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM is a medical device that received FDA 510(k) clearance on 1995-06-02. The listed applicant is Gulf Coast Hyperbarics, Inc.. The 510(k) number is K950957.

When did MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM receive FDA 510(k) clearance?

MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM received FDA 510(k) clearance on 1995-06-02, under 510(k) number K950957.

Who is the listed applicant for MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM?

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

What is the FDA product code for MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM?

The FDA product code for MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM is CBF.

Related Clinical Trials

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.

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Other records listing Gulf Coast Hyperbarics, 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.

K082455RECTANGULAR MULTIPLACE HYPERBARIC CHAMBERK011565INFANT OXYGEN TREATMENT HOOD

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

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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