FDA 510(k) Application Details - K231813

Device Classification Name	Endoscopic Ultrasound System, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K231813
Device Name	Endoscopic Ultrasound System, Gastroenterology-Urology
Applicant	Sonoscape Medical Corp. Room 201 & 202, 12th Building, Shenzhen Software Park Phase II, 1 Keji Middle 2nd Road, Yuehai Subdistrict, Nansha Shenzhen 518057 CN Other 510(k) Applications for this Company
Contact	Toki Wu Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	ODG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/2023
Decision Date	03/08/2024
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