FDA 510(k) Application Details - K171766

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

  More FDA Info for this Device
510(K) Number K171766
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant Siemens Medical Solutions Inc.
685 East Middlefield Road
Mountain View, CA 94043 US
Other 510(k) Applications for this Company
Contact Kevin Kong
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 06/14/2017
Decision Date 07/12/2017
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 Y
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact