Cleared Traditional

K972486 - PRESSUREGUARD IV
(FDA 510(k) Clearance)

K972486 · Span-America Medical Systems, Inc. · Physical Medicine

Feb 1998

Decision

233d

Days

Class 2

Risk

K972486 is an FDA 510(k) clearance for the PRESSUREGUARD IV, a Bed, Patient Rotation, Powered (Class II — Special Controls, product code IKZ), submitted by Span-America Medical Systems, Inc. (Greenville, US). The FDA issued a Cleared decision on February 20, 1998, 233 days after receiving the submission on July 2, 1997. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5225.

Submission Details

510(k) Number	K972486 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 02, 1997
Decision Date	February 20, 1998
Days to Decision	233 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF