FDA 510(k) Application Details - K161482

Device Classification Name	Pump, Air, Non-Manual, For Endoscope   More FDA Info for this Device
510(K) Number	K161482
Device Name	Pump, Air, Non-Manual, For Endoscope
Applicant	ENDOCHOICE, INC. 11810 WILLS RD. ALPHARETTA, GA 30009 US Other 510(k) Applications for this Company
Contact	DAINEL HOEFER Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FEQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/31/2016
Decision Date	06/27/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review