FDA 510(k) Application Details - K142197

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K142197
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	KONICA MINOLTA INC. 1 SAKUA-MACHI HINO-SHI 191-8511 JP Other 510(k) Applications for this Company
Contact	SHIGEYUKI KOJIMA 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	08/11/2014
Decision Date	11/21/2014
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