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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Isokinetic Testing And Evaluation
510(k) Number K895398
Device Name BIO-COORDINATOR SYSTEM
Applicant
Bio-Harmonizer, Inc.
1330 Connecticut Ave. NW
Suite 200
Washington D.C.,  20036
Applicant Contact JONATHAN GLAZIER
Correspondent
Bio-Harmonizer, Inc.
1330 Connecticut Ave. NW
Suite 200
Washington D.C.,  20036
Correspondent Contact JONATHAN GLAZIER
Regulation Number890.1925
Classification Product Code
IKK  
Date Received09/07/1989
Decision Date 09/28/1989
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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