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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 K943385
Device Name CLINITRON ELEXIS
Applicant
Ssi Medical Services, Inc.
4349 Corporate Rd.
Charleston,  SC  29405
Applicant Contact THOMAS E MCFADDEN
Correspondent
Ssi Medical Services, Inc.
4349 Corporate Rd.
Charleston,  SC  29405
Correspondent Contact THOMAS E MCFADDEN
Regulation Number890.5160
Classification Product Code
INX  
Date Received07/13/1994
Decision Date 02/27/1995
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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