FDA 510(k) Application Details - K213436

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K213436
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	Clarius Mobile Health Corp. 130-2985 Virtual Way Vancouver V5M 4X7 CA Other 510(k) Applications for this Company
Contact	Agatha Szeliga Other 510(k) Applications for this Contact
Regulation Number	892.1550   More FDA Info for this Regulation Number
Classification Product Code	IYN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/22/2021
Decision Date	11/15/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review