Cleared Traditional

Revitalair 430F

K171899 · Oxavita Srl · Anesthesiology

Nov 2019

Decision

879d

Days

Class 2

Risk

About This 510(k) Submission

K171899 is an FDA 510(k) clearance for the Revitalair 430F, a Chamber, Hyperbaric (Class II — Special Controls, product code CBF), submitted by Oxavita Srl (Buenos Aires, AR). The FDA issued a Cleared decision on November 22, 2019, 879 days after receiving the submission on June 26, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5470.

Submission Details

510(k) Number	K171899 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 26, 2017
Decision Date	November 22, 2019
Days to Decision	879 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF