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FDA 510(k) Application Details - K173526
Device Classification Name
More FDA Info for this Device
510(K) Number
K173526
Device Name
SENTIO MMG Gen 2
Applicant
Medos International, SARL
Chemin-Blanc 38
Le Locle 2400 CH
Other 510(k) Applications for this Company
Contact
Karen Sylvia
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PDQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/14/2017
Decision Date
04/05/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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