Cleared Traditional

SPR PLUS II OVERLAY SYSTEM (CL250/CL212

K961854 · Gaymar Industries, Inc. · General Hospital
Aug 1996
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K961854 is an FDA 510(k) clearance for the SPR PLUS II OVERLAY SYSTEM (CL250/CL212, a Mattress, Air Flotation, Alternating Pressure (Class II — Special Controls, product code FNM), submitted by Gaymar Industries, Inc. (Orchard Park, US). The FDA issued a Cleared decision on August 9, 1996, 87 days after receiving the submission on May 14, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5550.

Submission Details

510(k) Number K961854 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 1996
Decision Date August 09, 1996
Days to Decision 87 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