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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 K951001
Device Name FLEXICAIR EXLIPSE
Applicant
Hill-Rom, Inc.
4349 Corporate Rd.
Charleston,  SC  29405
Applicant Contact EDWIN BILLS
Correspondent
Hill-Rom, Inc.
4349 Corporate Rd.
Charleston,  SC  29405
Correspondent Contact EDWIN BILLS
Regulation Number890.5170
Classification Product Code
IOQ  
Subsequent Product Code
FNM  
Date Received03/03/1995
Decision Date 06/27/1995
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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