FDA 510(k) Application Details - K201597

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K201597
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	Sonic Incytes 560-828 West 10th Ave Vancouver v5z 1m9 CA Other 510(k) Applications for this Company
Contact	George Aliphtiras 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	06/12/2020
Decision Date	07/31/2020
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