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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 K924686
Device Name REM-AIR
Applicant
Mellenair Ent., Inc.
2107 San Vicente Ave.
Long Beach,  CA  90815
Applicant Contact ANTHONY DACOSTA
Correspondent
Mellenair Ent., Inc.
2107 San Vicente Ave.
Long Beach,  CA  90815
Correspondent Contact ANTHONY DACOSTA
Regulation Number890.5160
Classification Product Code
INX  
Date Received09/16/1992
Decision Date 02/12/1993
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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