Cleared Traditional

K931168 - X-20 AIR SUPPORT BED
(FDA 510(k) Clearance)

K931168 · American Life Support Technology, Inc. · Physical Medicine device

Feb 1994

Decision

346d

Days

Class 2

Risk

K931168 is an FDA 510(k) clearance for the X-20 AIR SUPPORT BED. This device is classified as a Bed, Air Fluidized (Class II - Special Controls, product code INX).

Submitted by American Life Support Technology, Inc. (Redwood City, US). The FDA issued a Cleared decision on February 17, 1994, 346 days after receiving the submission on March 8, 1993.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5160.

Submission Details

510(k) Number	K931168 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 08, 1993
Decision Date	February 17, 1994
Days to Decision	346 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF