FDA 510(k) Application Details - K161716

Device Classification Name	Device, Muscle Monitoring   More FDA Info for this Device
510(K) Number	K161716
Device Name	Device, Muscle Monitoring
Applicant	BTS S.P.A. VIA DELLA CROCE ROSSA 11 PADOVA 35129 IT Other 510(k) Applications for this Company
Contact	VERONICA BARTOLINI Other 510(k) Applications for this Contact
Regulation Number	890.1375   More FDA Info for this Regulation Number
Classification Product Code	KZM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/2016
Decision Date	12/21/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review