FDA 510(k) Application Details - K130058

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K130058
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	OLYMPUS MEDICAL SYSTEMS CORP. REGULATORY AFFAIRS & QUALITY ASSURANCE 3500 CORPORATE PARKWAY CENTER VALLEY, PA 18034-0610 US Other 510(k) Applications for this Company
Contact	DAPHNEY GERMAIN-KOLAWOLE 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	01/09/2013
Decision Date	02/22/2013
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