FDA 510(k) Application Details - K122009

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K122009
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	PANASONIC HEALTHCARE CO., LTD. 2425 SQUAK MOUNTAIN LOOP SW ISSAQUAH, WA 98027 US Other 510(k) Applications for this Company
Contact	RAM BEDI 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	07/09/2012
Decision Date	10/03/2012
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