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FDA 510(k)

INFANT OXYGEN TREATMENT HOOD

K-Number: K011565 · 2001-08-16

ApplicantGulf Coast Hyperbarics, Inc.
Decision Date2001-08-16
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INFANT OXYGEN TREATMENT HOOD 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 2001-08-16 under 510(k) number K011565. 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 INFANT OXYGEN TREATMENT HOOD?

INFANT OXYGEN TREATMENT HOOD is a medical device that received FDA 510(k) clearance on 2001-08-16. The listed applicant is Gulf Coast Hyperbarics, Inc.. The 510(k) number is K011565.

When did INFANT OXYGEN TREATMENT HOOD receive FDA 510(k) clearance?

INFANT OXYGEN TREATMENT HOOD received FDA 510(k) clearance on 2001-08-16, under 510(k) number K011565.

Who is the listed applicant for INFANT OXYGEN TREATMENT HOOD?

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 INFANT OXYGEN TREATMENT HOOD?

The FDA product code for INFANT OXYGEN TREATMENT HOOD 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 CHAMBERK950957MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM

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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