FDA 510(k) Application Details - K241591

Device Classification Name	More FDA Info for this Device
510(K) Number	K241591
Device Name	Blue Eye
Applicant	The Standard Co., Ltd. 120, Gunpocheomdansaneop 2-ro Gunpo-si 15880 KR Other 510(k) Applications for this Company
Contact	Seong Nam Kim Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/03/2024
Decision Date	07/03/2024
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