FDA 510(k) Application Details - K213488

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K213488
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	Suzhou Peaksonic Medical Technology Co., Ltd. 2A, West Side of Building G4, Kunshan Hi-Tech Medical Device Industrial Park Qiandeng, Kunshan Suzhou 215341 CN Other 510(k) Applications for this Company
Contact	Calvin Ma Other 510(k) Applications for this Contact
Regulation Number	892.1560   More FDA Info for this Regulation Number
Classification Product Code	IYO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/01/2021
Decision Date	07/01/2022
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