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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Flotation Therapy, Powered
510(k) Number K883192
Device Name SMI 3000 AIRBED
Applicant
Smi Patientcare, Inc.
815 Terminal Rd.
Lansing,  MI  48906
Applicant Contact DONALD PROPP
Correspondent
Smi Patientcare, Inc.
815 Terminal Rd.
Lansing,  MI  48906
Correspondent Contact DONALD PROPP
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received07/28/1988
Decision Date 10/26/1988
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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