FDA 510(k) Application Details - K231249

Device Classification Name	More FDA Info for this Device
510(K) Number	K231249
Device Name	PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL
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	05/01/2023
Decision Date	07/28/2023
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