Revitalair 430F

Chamber, Hyperbaric

Oxavita S.R.L.

The following data is part of a premarket notification filed by Oxavita S.r.l. with the FDA for Revitalair 430f.

Pre-market Notification Details

Device IDK171899
501k NumberK171899
Device Name:Revitalair 430F
ClassificationChamber, Hyperbaric
Applicant Oxavita S.R.L. Tamborini 5813 Buenos Aires,  AR
ContactEduardo Northing
CorrespondentDiane Sudduth
Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin,  TX  78746
Product CodeCBF  
CFR Regulation Number868.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyAnesthesiology
501k Review PanelAnesthesiology
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-26
Decision Date2019-11-22

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