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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Muscle Monitoring
510(k) Number K873947
Device Name BIO-EMG MODEL 800
Applicant
Bio-Research Associates, Inc.
4113 N. Port Washington Rd.
Milwaukee,  WI  53212
Applicant Contact JOHN C RADKE
Correspondent
Bio-Research Associates, Inc.
4113 N. Port Washington Rd.
Milwaukee,  WI  53212
Correspondent Contact JOHN C RADKE
Regulation Number890.1375
Classification Product Code
KZM  
Date Received09/28/1987
Decision Date 04/27/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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