Cleared Traditional

POWERED LOW AIR LOSS MATTRESS SYSTEM

K961159 · Span-America Medical Systems, Inc. · General Hospital
Jun 1996
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K961159 is an FDA 510(k) clearance for the POWERED 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 June 14, 1996, 84 days after receiving the submission on March 22, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5550.

Submission Details

510(k) Number K961159 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 1996
Decision Date June 14, 1996
Days to Decision 84 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