Cleared Special

OxyHeal 4000 Multiplace Hyperbaric Chamber Family

K163109 · Oxyheal Medical Systems, Inc. · Anesthesiology

Mar 2017

Decision

135d

Days

Class 2

Risk

About This 510(k) Submission

K163109 is an FDA 510(k) clearance for the OxyHeal 4000 Multiplace Hyperbaric Chamber Family, a Chamber, Hyperbaric (Class II — Special Controls, product code CBF), submitted by Oxyheal Medical Systems, Inc. (National City, US). The FDA issued a Cleared decision on March 22, 2017, 135 days after receiving the submission on November 7, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5470.

Submission Details

510(k) Number	K163109 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 07, 2016
Decision Date	March 22, 2017
Days to Decision	135 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF