Cleared Traditional

AIRTEC2 LOW AIR LOSS THERAPY BED

K970364 · Apex Metal, Inc. · Physical Medicine

Nov 1997

Decision

290d

Days

Class 2

Risk

About This 510(k) Submission

K970364 is an FDA 510(k) clearance for the AIRTEC2 LOW AIR LOSS THERAPY BED, a Bed, Flotation Therapy, Powered (Class II — Special Controls, product code IOQ), submitted by Apex Metal, Inc. (Mt Pleasant, US). The FDA issued a Cleared decision on November 17, 1997, 290 days after receiving the submission on January 31, 1997. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5170.

Submission Details

510(k) Number	K970364 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 31, 1997
Decision Date	November 17, 1997
Days to Decision	290 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement