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)

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 a medical device manufactured by Us Hyperbaric Network. It received FDA 510(k) clearance on 2023-05-04 under approval 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. It is manufactured by Us Hyperbaric Network. The 510(k) number is K220290.

When was Revitalair 430+ approved by the FDA?

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

What company makes Revitalair 430+?

Revitalair 430+ is manufactured by Us Hyperbaric Network.

What is the FDA product code for Revitalair 430+?

The FDA product code for Revitalair 430+ is CBF.

Related Devices (Code: CBF)

K152223Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control SystemOxyheal Medical Systems, Inc. K163109OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyOxyheal Medical Systems, Inc. K171899Revitalair 430FOxavita Srl 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.

↑