Cleared Traditional

PRESSUREGUARD IV

K953503 · Span-America Medical Systems, Inc. · General Hospital
Oct 1995
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K953503 is an FDA 510(k) clearance for the PRESSUREGUARD IV, 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 24, 1995, 90 days after receiving the submission on July 26, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5550.

Submission Details

510(k) Number K953503 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 1995
Decision Date October 24, 1995
Days to Decision 90 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