Cleared Traditional

BARIAIR

K955243 · Kinetic Concepts, Inc. · General Hospital
Oct 1997
Decision
708d
Days
Class 2
Risk

About This 510(k) Submission

K955243 is an FDA 510(k) clearance for the BARIAIR, a Mattress, Air Flotation, Alternating Pressure (Class II — Special Controls, product code FNM), submitted by Kinetic Concepts, Inc. (San Antonio, US). The FDA issued a Cleared decision on October 23, 1997, 708 days after receiving the submission on November 15, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5550.

Submission Details

510(k) Number K955243 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 1995
Decision Date October 23, 1997
Days to Decision 708 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