Cleared Traditional

PRESSUREGUARD: SELECTCARE

K960188 · Span-America Medical Systems, Inc. · General Hospital
Oct 1996
Decision
260d
Days
Class 2
Risk

About This 510(k) Submission

K960188 is an FDA 510(k) clearance for the PRESSUREGUARD: SELECTCARE, 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 October 2, 1996, 260 days after receiving the submission on January 16, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5550.

Submission Details

510(k) Number K960188 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 1996
Decision Date October 02, 1996
Days to Decision 260 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