Cleared Traditional

PRESSURE GUARD ALTERNATING PRESSURE MATTRESS

K954766 · Span-America Medical Systems, Inc. · General Hospital
Jan 1996
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K954766 is an FDA 510(k) clearance for the PRESSURE GUARD ALTERNATING PRESSURE MATTRESS, a Mattress, Air Flotation, Alternating Pressure (Class II — Special Controls, product code FNM), submitted by Span-America Medical Systems, Inc. (Greenville, US). The FDA issued a Cleared decision on January 11, 1996, 86 days after receiving the submission on October 17, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5550.

Submission Details

510(k) Number K954766 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 1995
Decision Date January 11, 1996
Days to Decision 86 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FNM — Mattress, Air Flotation, Alternating Pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5550