FDA 510(k) Application Details - K002856

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K002856
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	SONORA MEDICAL SYSTEMS 7992 CASTLEWAY DR. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	COLLEEN HITTLE Other 510(k) Applications for this Contact
Regulation Number	892.1570   More FDA Info for this Regulation Number
Classification Product Code	ITX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/13/2000
Decision Date	04/02/2001
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