Cleared Traditional

LAKE STAGEZERO(TM) AIR FLOTATION BED

K943162 · Lake Medical Products, Inc. · General Hospital
Feb 1995
Decision
241d
Days
Class 2
Risk

About This 510(k) Submission

K943162 is an FDA 510(k) clearance for the LAKE STAGEZERO(TM) AIR FLOTATION BED, a Mattress, Air Flotation, Alternating Pressure (Class II — Special Controls, product code FNM), submitted by Lake Medical Products, Inc. (North Brunswick, US). The FDA issued a Cleared decision on February 27, 1995, 241 days after receiving the submission on July 1, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5550.

Submission Details

510(k) Number K943162 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1994
Decision Date February 27, 1995
Days to Decision 241 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