FDA 510(k) Application Details - K191282

Device Classification Name	More FDA Info for this Device
510(K) Number	K191282
Device Name	PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family
Applicant	PENTAX of America, Inc. 3 Paragon Drive Montvale, NJ 07645-1782 US Other 510(k) Applications for this Company
Contact	William Goeller Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/13/2019
Decision Date	11/08/2019
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