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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mattress, Air Flotation, Alternating Pressure
510(k) Number K901901
Device Name PROFILE, A CRITICAL CARE LOW AIR LOSS BED
Applicant
Kinetic Concepts, Inc.
4958 Stout Dr.
San Antonio,  TX  78219
Applicant Contact ROBERT A WEHRMEYER
Correspondent
Kinetic Concepts, Inc.
4958 Stout Dr.
San Antonio,  TX  78219
Correspondent Contact ROBERT A WEHRMEYER
Regulation Number880.5550
Classification Product Code
FNM  
Date Received04/27/1990
Decision Date 10/03/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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