FDA 510(k) Application Details - K163313

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K163313
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	CIVCO MEDICAL INSTRUMENTS CO., INC. (D/B/A CIVCO MEDICAL SOLUTIONS) 6 WINTER AVE Deep River, CT 06417 US Other 510(k) Applications for this Company
Contact	Kevin Mader 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	11/23/2016
Decision Date	06/09/2017
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