Arema II

FDA 510(k) K961129 · Mellen Air Mfg., Inc.

Substantially Equivalent

510(k) numberK961129

Submission

Device name
Arema II
Applicant
Mellen Air Mfg., Inc.
Long Beach, CA, US
Received
March 21, 1996
Decision date
April 17, 1996
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

Other 510(k)s with product code FNM

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K973169Pressure Guard Site Select (a)FNM · Traditional Span-America Medical Systems, Inc.02/20/1998SE
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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
K963510Aprema I - Alternating Pressure Air Flotation Mattress SystemFNM · Traditional 11/26/1996SE

Questions and answers

When was Arema II cleared by the FDA?

Arema II (K961129) received a 510(k) decision of Substantially Equivalent on April 17, 1996, 27 days after the submission was received.

What is the product code of K961129?

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