FDA 510(k) Application Details - K222460

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K222460
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	Exact Medical Manufacturing 21# Qingjjiang Rd XinBei District Changzhou Jiangsu 213022 CN Other 510(k) Applications for this Company
Contact	Ryan Power Other 510(k) Applications for this Contact
Regulation Number	892.1570   More FDA Info for this Regulation Number
Classification Product Code	ITX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/15/2022
Decision Date	05/12/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review