Simpulse

FDA 510(k) K972549 · Kinetic Concepts, Inc.

Substantially Equivalent

510(k) numberK972549

Submission

Device name
Simpulse
Applicant
Kinetic Concepts, Inc.
San Antonio, TX, US
Received
July 8, 1997
Decision date
November 18, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FNM – Mattress, Air Flotation, Alternating Pressure
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5550
Specialty
General Hospital

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K972022ZAK-2000FNM · Traditional Cardio Systems, Inc.01/22/1998SE
K974070PHYSIO/1000FNM · Traditional Physio Designs, Inc.01/06/1998SE
K970081Super Air 9000 Alternating Air Floatation Mattress SystemFNM · Traditional Cathay Consolidated, Inc.11/07/1997SE
K955243BariairFNM · Traditional Kinetic Concepts, Inc.10/23/1997SE
K970468KT Air BedFNM · Traditional Kinetic Concepts, Inc.09/05/1997SE
K965207Rid-Decube IIFNM · Traditional Skin Care Management, Inc.08/21/1997SE
K972153Alternating Pressure Air Flotation MattressFNM · Traditional Decubiti Concepts, Inc.07/31/1997SE
K971568Rest MattressFNM · Traditional Rest Mattress07/18/1997SE

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Questions and answers

When was Simpulse cleared by the FDA?

Simpulse (K972549) received a 510(k) decision of Substantially Equivalent on November 18, 1997, 133 days after the submission was received.

What is the product code of K972549?

The FDA product code is FNM – Mattress, Air Flotation, Alternating Pressure, a Class II (moderate risk) device regulated under 21 CFR 880.5550.