FDA 510(k) Application Details - K083882

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K083882
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	ESAOTE EUROPE B.V. 11460 N. MERIDIAN STREET SUITE 150 CARMEL, IN 46032 US Other 510(k) Applications for this Company
Contact	JAMIE AUSTIN 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	12/29/2008
Decision Date	01/30/2009
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	Y
Expedited Review