Cleared Traditional

K220290 - Revitalair 430+
(FDA 510(k) Clearance)

K220290 · Us Hyperbaric Network · Anesthesiology

May 2023

Decision

457d

Days

Class 2

Risk

K220290 is an FDA 510(k) clearance for the Revitalair 430+, a Chamber, Hyperbaric (Class II — Special Controls, product code CBF), submitted by Us Hyperbaric Network (Medley, US). The FDA issued a Cleared decision on May 4, 2023, 457 days after receiving the submission on February 1, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5470.

Submission Details

510(k) Number	K220290 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 2022
Decision Date	May 04, 2023
Days to Decision	457 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF