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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Radiographic, Tilting
510(k) Number K950981
Device Name ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650
Applicant
Biodex Medical Systems, Inc.
Brookhaven R & D Plz.
20 Ramsey Rd., P.O. Box 702
Shirley,  NY  11967
Applicant Contact CLYDE SCHLEIN
Correspondent
Biodex Medical Systems, Inc.
Brookhaven R & D Plz.
20 Ramsey Rd., P.O. Box 702
Shirley,  NY  11967
Correspondent Contact CLYDE SCHLEIN
Regulation Number892.1980
Classification Product Code
IXR  
Date Received03/03/1995
Decision Date 04/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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