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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name exerciser, measuring
510(k) Number K850869
Device Name MFE COUCH ERGOMETER
Applicant
KETRONIC, INC.
DUINKERKENLAAN 31
5627 MA EINDHOVEN
THE NETHERLANDS,  NL
Applicant Contact VANDILL
Correspondent
KETRONIC, INC.
DUINKERKENLAAN 31
5627 MA EINDHOVEN
THE NETHERLANDS,  NL
Correspondent Contact VANDILL
Regulation Number890.5360
Classification Product Code
ISD  
Date Received03/01/1985
Decision Date 06/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
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