FDA 510(k) Application Details - K130158

Device Classification Name Device, Muscle Monitoring

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510(K) Number K130158
Device Name Device, Muscle Monitoring
Applicant BIO-RESEARCH ASSOCIATES, INC.
4555 W Schroeder Dr Ste 100
BROWN DEER, WI 53223 US
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Contact JOHN RADKE
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Regulation Number 890.1375

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Classification Product Code KZM
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Date Received 01/23/2013
Decision Date 07/25/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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