FDA 510(k)

Revitalair 430F

K-Number: K171899 · 2019-11-22

Decision Date2019-11-22

Product CodeCBF

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Revitalair 430F is the device name listed in this FDA 510(k) record. The listed applicant is Oxavita Srl. It received FDA 510(k) clearance on 2019-11-22 under 510(k) number K171899. 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 430F?

Revitalair 430F is a medical device that received FDA 510(k) clearance on 2019-11-22. The listed applicant is Oxavita Srl. The 510(k) number is K171899.

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

Revitalair 430F received FDA 510(k) clearance on 2019-11-22, under 510(k) number K171899.

Who is the listed applicant for Revitalair 430F?

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

What is the FDA product code for Revitalair 430F?

The FDA product code for Revitalair 430F 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.K220290Revitalair 430+Us Hyperbaric Network K163109OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyOxyheal Medical Systems, Inc.K152223Rectangular 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.