Cleared Traditional

PRESSUREGUARD IV

K932681 · Span-America Medical Systems, Inc. · General Hospital
Nov 1993
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K932681 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 November 12, 1993, 162 days after receiving the submission on June 3, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5550.

Submission Details

510(k) Number K932681 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 1993
Decision Date November 12, 1993
Days to Decision 162 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