Cleared Traditional

Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System

K152223 · Oxyheal Medical Systems, Inc. · Anesthesiology

Apr 2016

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K152223 is an FDA 510(k) clearance for the Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System, 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 April 29, 2016, 266 days after receiving the submission on August 7, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5470.

Submission Details

510(k) Number	K152223 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 07, 2015
Decision Date	April 29, 2016
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF