FDA 510(k) Application Details - K213279

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K213279
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	NovaSignal Corporation 2440 S. Sepulveda Blvd., Ste 115 Los Angeles, CA 90064 US Other 510(k) Applications for this Company
Contact	Raajdeep (Raaj) Venkatesan 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	10/01/2021
Decision Date	03/02/2022
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