Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Oxyheal Medical Systems, Inc.. It received FDA 510(k) clearance on 2017-03-22 under approval 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. It is manufactured by Oxyheal Medical Systems, Inc.. The 510(k) number is K163109.

When was OxyHeal 4000 Multiplace Hyperbaric Chamber Family approved by the FDA?

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

What company makes OxyHeal 4000 Multiplace Hyperbaric Chamber Family?

OxyHeal 4000 Multiplace Hyperbaric Chamber Family is manufactured by Oxyheal Medical Systems, Inc..

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.

Related Clinical Trials

NCT06579040 The HEROES Trial: Hyperbaric Oxygen Therapy for Endometriosis-Related Pain RECRUITING

Other Devices by Oxyheal Medical Systems, Inc.

K152223Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System

Related Devices (Code: CBF)

K152223Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control SystemOxyheal 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.

↑