Medsentry Softouch System

FDA 510(k) K844499 · Medsentry Corp.

Substantially Equivalent

510(k) numberK844499

Submission

Device name
Medsentry Softouch System
Applicant
Medsentry Corp.
Santa Barbara, CA, US
Received
November 20, 1984
Decision date
January 30, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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
K972549SimpulseFNM · Traditional Kinetic Concepts, Inc.11/18/1997SE
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

More from Decubiti Concepts, Inc.

510(k)DeviceDecision
K863152Medsentry Flotation SystemFNM · Traditional 09/23/1986SE

Questions and answers

When was Medsentry Softouch System cleared by the FDA?

Medsentry Softouch System (K844499) received a 510(k) decision of Substantially Equivalent on January 30, 1985, 71 days after the submission was received.

What is the product code of K844499?

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