FDA 510(k) Application Details - K203657

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K203657
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	Crystalline Medical 48890 Milmont Drive Suite 106D Fremont, CA 94538 US Other 510(k) Applications for this Company
Contact	Ivan Ma 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	12/15/2020
Decision Date	06/25/2021
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	Y
Expedited Review