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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K970051
Device Name MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE
Applicant
Smith and Nephew Donjoy, Inc.
2777 Loker Ave. W.
Carsbad,  CA  92008
Applicant Contact DAN W MILLER
Correspondent
Smith and Nephew Donjoy, Inc.
2777 Loker Ave. W.
Carsbad,  CA  92008
Correspondent Contact DAN W MILLER
Regulation Number882.5050
Classification Product Code
HCC  
Date Received01/07/1997
Decision Date 07/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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