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FDA 510(k)

Revitalair 430F

K-Number: K171899 · 2019-11-22

ApplicantOxavita Srl
Decision Date2019-11-22
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Revitalair 430F is a medical device manufactured by Oxavita Srl. It received FDA 510(k) clearance on 2019-11-22 under approval 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. It is manufactured by Oxavita Srl. The 510(k) number is K171899.

When was Revitalair 430F approved by the FDA?

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

What company makes Revitalair 430F?

Revitalair 430F is manufactured by Oxavita Srl.

What is the FDA product code for Revitalair 430F?

The FDA product code for Revitalair 430F 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. 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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