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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 K963202
Device Name MEGA ME 3000 PROFESSIONAL MUSCLE TESTER
Applicant
Mega Electronics , Ltd.
1660 Riverton Point
Eagan,  MN  55122
Applicant Contact GREGORY J MATHISON
Correspondent
Mega Electronics , Ltd.
1660 Riverton Point
Eagan,  MN  55122
Correspondent Contact GREGORY J MATHISON
Regulation Number882.5050
Classification Product Code
HCC  
Date Received08/15/1996
Decision Date 05/19/1997
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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