FDA 510(k) Application Details - K012253

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K012253
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	ALOKA CO., LTD. 10 FAIRFIELD BLVD. WALLINGFORD, CT 06492 US Other 510(k) Applications for this Company
Contact	KELVIN BURROUGHS 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	07/18/2001
Decision Date	08/30/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review