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FDA 510(k)

OxyHeal 4000 Multiplace Hyperbaric Chamber Family

K-Number: K163109 · 2017-03-22

ApplicantOxyheal Medical Systems, Inc.
Decision Date2017-03-22
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OxyHeal 4000 Multiplace Hyperbaric Chamber Family is the device name listed in this FDA 510(k) record. The listed applicant is Oxyheal Medical Systems, Inc.. It received FDA 510(k) clearance on 2017-03-22 under 510(k) number K163109. 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 4000 Multiplace Hyperbaric Chamber Family?

OxyHeal 4000 Multiplace Hyperbaric Chamber Family is a medical device that received FDA 510(k) clearance on 2017-03-22. The listed applicant is Oxyheal Medical Systems, Inc.. The 510(k) number is K163109.

When did OxyHeal 4000 Multiplace Hyperbaric Chamber Family receive FDA 510(k) clearance?

OxyHeal 4000 Multiplace Hyperbaric Chamber Family received FDA 510(k) clearance on 2017-03-22, under 510(k) number K163109.

Who is the listed applicant for OxyHeal 4000 Multiplace Hyperbaric Chamber Family?

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

What is the FDA product code for OxyHeal 4000 Multiplace Hyperbaric Chamber Family?

The FDA product code for OxyHeal 4000 Multiplace Hyperbaric Chamber Family is CBF.

Other records listing Oxyheal Medical Systems, 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.

K152223Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control 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 SrlK152223Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control SystemOxyheal Medical 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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