Cleared Traditional

PRESSURE GUARD SITE SELECT (A)

K973169 · Span-America Medical Systems, Inc. · General Hospital
Feb 1998
Decision
179d
Days
Class 2
Risk

About This 510(k) Submission

K973169 is an FDA 510(k) clearance for the PRESSURE GUARD SITE SELECT (A), 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 February 20, 1998, 179 days after receiving the submission on August 25, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5550.

Submission Details

510(k) Number K973169 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 1997
Decision Date February 20, 1998
Days to Decision 179 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