Cleared Traditional

SIMPULSE

K972549 · Kinetic Concepts, Inc. · General Hospital
Nov 1997
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K972549 is an FDA 510(k) clearance for the SIMPULSE, 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 November 18, 1997, 133 days after receiving the submission on July 8, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5550.

Submission Details

510(k) Number K972549 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 1997
Decision Date November 18, 1997
Days to Decision 133 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