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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 K852036
Device Name AIR PLUS AIR FLUIDIZED THERAPY SYSTEMS
Applicant
Air Plus, Inc.
8517 NW 66th. St.
Miami,  FL  33166
Applicant Contact JACK H HESS
Correspondent
Air Plus, Inc.
8517 NW 66th. St.
Miami,  FL  33166
Correspondent Contact JACK H HESS
Regulation Number890.5160
Classification Product Code
INX  
Date Received05/09/1985
Decision Date 09/05/1985
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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