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FDA 510(k)

HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS

K-Number: K081506 · 2008-07-25

ApplicantHyperbaric America, LLC
Decision Date2008-07-25
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Hyperbaric America, LLC. It received FDA 510(k) clearance on 2008-07-25 under 510(k) number K081506. 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 HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS?

HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS is a medical device that received FDA 510(k) clearance on 2008-07-25. The listed applicant is Hyperbaric America, LLC. The 510(k) number is K081506.

When did HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS receive FDA 510(k) clearance?

HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS received FDA 510(k) clearance on 2008-07-25, under 510(k) number K081506.

Who is the listed applicant for HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS?

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

What is the FDA product code for HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS?

The FDA product code for HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS 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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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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