FDA 510(k) Application Details - K172380

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

  More FDA Info for this Device
510(K) Number K172380
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant Edan Instruments Inc
#15 Jinhui Road, Jinsha Community, Kengzi Sub-District
Pingshan District
Shenzhen 518067 CN
Other 510(k) Applications for this Company
Contact Alice Yang
Other 510(k) Applications for this Contact
Regulation Number 892.1550

  More FDA Info for this Regulation Number
Classification Product Code IYN
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 08/07/2017
Decision Date 09/29/2017
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



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