FDA 510(k) Application Details - K221590

Device Classification Name	System, Imaging, Gastrointestinal, Wireless, Capsule   More FDA Info for this Device
510(K) Number	K221590
Device Name	System, Imaging, Gastrointestinal, Wireless, Capsule
Applicant	ANKON Technologies Co., Ltd. B3-2, B3-3, D3-4 Biolake, No.666, Hi-Tech Road Wuhan 430075 CN Other 510(k) Applications for this Company
Contact	Si Feng Wang Other 510(k) Applications for this Contact
Regulation Number	876.1300   More FDA Info for this Regulation Number
Classification Product Code	NEZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/2022
Decision Date	12/02/2022
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