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FDA 510(k)

OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER

K-Number: K052866 · 2005-12-13

ApplicantOxyheal Health Group
Decision Date2005-12-13
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER is the device name listed in this FDA 510(k) record. The listed applicant is Oxyheal Health Group. It received FDA 510(k) clearance on 2005-12-13 under 510(k) number K052866. 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 OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER?

OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER is a medical device that received FDA 510(k) clearance on 2005-12-13. The listed applicant is Oxyheal Health Group. The 510(k) number is K052866.

When did OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER receive FDA 510(k) clearance?

OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER received FDA 510(k) clearance on 2005-12-13, under 510(k) number K052866.

Who is the listed applicant for OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER?

The FDA 510(k) record lists Oxyheal Health Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER?

The FDA product code for OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER is CBF.

Related Clinical Trials

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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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