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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Air Fluidized
510(k) Number K881917
Device Name FLUIDAIR
Applicant
Kinetic Concepts, Inc.
3440 E. Houston St.
San Antonio,  TX  78219
Applicant Contact ROBERT A WEHRMEYER
Correspondent
Kinetic Concepts, Inc.
3440 E. Houston St.
San Antonio,  TX  78219
Correspondent Contact ROBERT A WEHRMEYER
Regulation Number890.5160
Classification Product Code
INX  
Date Received05/09/1988
Decision Date 11/14/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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