FDA 510(k) Application Details - K161999

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K161999
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	SUPERSONIC IMAGINE Les Jardins de La Duranne-bat E & F, 510 Rue Rene Descartes AIX-EN-PROVENCE 13857 FR Other 510(k) Applications for this Company
Contact	LAURENCE HERMITTE 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	07/20/2016
Decision Date	11/16/2016
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