FDA 510(k) Application Details - K102027

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K102027
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	QUANTEL MEDICAL S.A. 601 HAGGERTY LANE BOZEMAN, MT 59715 US Other 510(k) Applications for this Company
Contact	MICHAEL JOHNSON Other 510(k) Applications for this Contact
Regulation Number	892.1560   More FDA Info for this Regulation Number
Classification Product Code	IYO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/19/2010
Decision Date	12/22/2010
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