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FDA 510(k)

Revitalair 430+

K-Number: K220290 · 2023-05-04

ApplicantUs Hyperbaric Network
Decision Date2023-05-04
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Revitalair 430+ is the device name listed in this FDA 510(k) record. The listed applicant is Us Hyperbaric Network. It received FDA 510(k) clearance on 2023-05-04 under 510(k) number K220290. 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 Revitalair 430+?

Revitalair 430+ is a medical device that received FDA 510(k) clearance on 2023-05-04. The listed applicant is Us Hyperbaric Network. The 510(k) number is K220290.

When did Revitalair 430+ receive FDA 510(k) clearance?

Revitalair 430+ received FDA 510(k) clearance on 2023-05-04, under 510(k) number K220290.

Who is the listed applicant for Revitalair 430+?

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

What is the FDA product code for Revitalair 430+?

The FDA product code for Revitalair 430+ is CBF.

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.K171899Revitalair 430FOxavita SrlK163109OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyOxyheal Medical Systems, Inc.K152223Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control SystemOxyheal Medical 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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