Cleared Traditional

BAZOOKA SYSTEM

K951469 · Innovative Medical Systems, Inc. · General Hospital
Jun 1995
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K951469 is an FDA 510(k) clearance for the BAZOOKA SYSTEM, a Mattress, Air Flotation, Alternating Pressure (Class II — Special Controls, product code FNM), submitted by Innovative Medical Systems, Inc. (Manchester, US). The FDA issued a Cleared decision on June 28, 1995, 90 days after receiving the submission on March 30, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5550.

Submission Details

510(k) Number K951469 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 1995
Decision Date June 28, 1995
Days to Decision 90 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