FDA 510(k) Application Details - K131528

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K131528
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	CIVCO MEDICAL INSTRUMENTS CO., INC. 102 FIRST ST. SOUTH KALONA, IA 52247 US Other 510(k) Applications for this Company
Contact	AMANDA STAHLE 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	05/28/2013
Decision Date	06/11/2013
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	Y
Expedited Review