FDA 510(k) Application Details - K161785

Device Classification Name	Monitor, Esophageal Motility, And Tube   More FDA Info for this Device
510(K) Number	K161785
Device Name	Monitor, Esophageal Motility, And Tube
Applicant	THD SPA VIA DELL'INDUSTRIA 1 CORREGGIO 42015 IT Other 510(k) Applications for this Company
Contact	GIUSEPPINA GIANNINI Other 510(k) Applications for this Contact
Regulation Number	876.1725   More FDA Info for this Regulation Number
Classification Product Code	KLA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/29/2016
Decision Date	03/14/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review