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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 K981563
Device Name BIOPAK MEASUREMENT SYSTEM
Applicant
Bio-Research Associates, Inc.
4113 N. Port Washington Rd.
Milwaukee,  WI  53212
Correspondent
Bio-Research Associates, Inc.
4113 N. Port Washington Rd.
Milwaukee,  WI  53212
Regulation Number890.1375
Classification Product Code
KZM  
Subsequent Product Codes
NFQ   NFS  
Date Received05/01/1998
Decision Date 09/15/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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