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FDA 510(k)

Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System

K-Number: K152223 · 2016-04-29

ApplicantOxyheal Medical Systems, Inc.
Decision Date2016-04-29
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System is a medical device manufactured by Oxyheal Medical Systems, Inc.. It received FDA 510(k) clearance on 2016-04-29 under approval number K152223. 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 Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System?

Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System is a medical device that received FDA 510(k) clearance on 2016-04-29. It is manufactured by Oxyheal Medical Systems, Inc.. The 510(k) number is K152223.

When was Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System approved by the FDA?

Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System received FDA 510(k) clearance on 2016-04-29, under approval number K152223.

What company makes Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System?

Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System is manufactured by Oxyheal Medical Systems, Inc..

What is the FDA product code for Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System?

The FDA product code for Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System is CBF.

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Related PubMed Literature

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Other Devices by Oxyheal Medical Systems, Inc.

K163109OxyHeal 4000 Multiplace Hyperbaric Chamber Family

Related Devices (Code: CBF)

K163109OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyOxyheal Medical Systems, Inc. K171899Revitalair 430FOxavita Srl K220290Revitalair 430+Us Hyperbaric Network K240569FESL FINK Chamber; FEDL FINK Chamber; FETL FINK ChamberFink Engineering Pty, Ltd.

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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