Cleared Traditional

PRESSUREGUARD IV

K951112 · Span-America Medical Systems, Inc. · General Hospital
Jun 1995
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K951112 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 June 6, 1995, 88 days after receiving the submission on March 10, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5550.

Submission Details

510(k) Number K951112 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 1995
Decision Date June 06, 1995
Days to Decision 88 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