Cleared Traditional

SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM

K970081 · Cathay Consolidated, Inc. · General Hospital
Nov 1997
Decision
302d
Days
Class 2
Risk

About This 510(k) Submission

K970081 is an FDA 510(k) clearance for the SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM, a Mattress, Air Flotation, Alternating Pressure (Class II — Special Controls, product code FNM), submitted by Cathay Consolidated, Inc. (Taipei, TW). The FDA issued a Cleared decision on November 7, 1997, 302 days after receiving the submission on January 9, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5550.

Submission Details

510(k) Number K970081 FDA.gov
FDA Decision Cleared SESE
Date Received January 09, 1997
Decision Date November 07, 1997
Days to Decision 302 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FNM — Mattress, Air Flotation, Alternating Pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5550