Proact CLA-1500 System

FDA 510(k) K915061 · Clinical Systems, Inc.

Substantially Equivalent

510(k) numberK915061

Submission

Device name
Proact CLA-1500 System
Applicant
Clinical Systems, Inc.
Orchard Park, NY, US
Received
November 8, 1991
Decision date
January 31, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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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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.

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K921050Ultraflo Ratesaver Plus Infusion PumpFRN · Traditional 08/03/1993SE
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Questions and answers

When was Proact CLA-1500 System cleared by the FDA?

Proact CLA-1500 System (K915061) received a 510(k) decision of Substantially Equivalent on January 31, 1992, 84 days after the submission was received.

What is the product code of K915061?

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