Cleared Traditional

PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM

K960620 · Span-America Medical Systems, Inc. · General Hospital
Apr 1996
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K960620 is an FDA 510(k) clearance for the PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM, 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 April 25, 1996, 72 days after receiving the submission on February 13, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5550.

Submission Details

510(k) Number K960620 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 1996
Decision Date April 25, 1996
Days to Decision 72 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