FDA 510(k) Application Details - K213102

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K213102
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	E-Scopics 931 Chemin De La Bosque D'Antonelle Aix-en-Provence 13090 FR Other 510(k) Applications for this Company
Contact	Claude Cohen-Bacrie 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	09/24/2021
Decision Date	01/11/2022
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