Cleared Traditional

K970362 - CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM
(FDA 510(k) Clearance)

K970362 · Apex Metal, Inc. · General Hospital

May 1997

Decision

105d

Days

Class 2

Risk

K970362 is an FDA 510(k) clearance for the CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM. This device is classified as a Mattress, Air Flotation, Alternating Pressure (Class II - Special Controls, product code FNM).

Submitted by Apex Metal, Inc. (Los Angeles, US). The FDA issued a Cleared decision on May 16, 1997, 105 days after receiving the submission on January 31, 1997.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5550.

Submission Details

510(k) Number	K970362 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 31, 1997
Decision Date	May 16, 1997
Days to Decision	105 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement