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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 K113677
Device Name GRINDCARE MEASURE
Applicant
Medotech A/S
13417 Quivas St.
Westminster,  CO  80234
Applicant Contact Calley Herzog
Correspondent
Medotech A/S
13417 Quivas St.
Westminster,  CO  80234
Correspondent Contact Calley Herzog
Regulation Number890.1375
Classification Product Code
KZM  
Date Received12/14/2011
Decision Date 04/05/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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