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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 NORTH PORT WASHINGTON RD.
MILWAUKEE,  WI  53212
Correspondent
BIO-RESEARCH ASSOCIATES, INC.
4113 NORTH 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
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