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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 K161716
Device Name TEETHAN 2.0
Applicant
Bts S.P.A.
Via Della Croce Rossa 11
Padova,  IT 35129
Applicant Contact VERONICA BARTOLINI
Correspondent
Namsa
4050 Olson Memorial Hwy.
Suite 450
Minneapolis,  MN  55422
Correspondent Contact JULIE SHERMAN
Regulation Number890.1375
Classification Product Code
KZM  
Date Received06/21/2016
Decision Date 12/21/2016
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
Predetermined Change
Control Plan Authorized		 No
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