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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Goniometer, Ac-Powered
510(k) Number K884611
Device Name THE ORTHORANGER II ELECTRONIC GONIOMETER
Applicant
Medical Instruments Technology, Inc.
1199 N. Fairfax St.
Suite 601
Alexandria,  VA  22314
Applicant Contact PHILIP M SHAPIRO
Correspondent
Medical Instruments Technology, Inc.
1199 N. Fairfax St.
Suite 601
Alexandria,  VA  22314
Correspondent Contact PHILIP M SHAPIRO
Regulation Number888.1500
Classification Product Code
KQX  
Date Received11/04/1988
Decision Date 01/31/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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