FDA 510(k) Application Details - K201693

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

  More FDA Info for this Device
510(K) Number K201693
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Building, Keji 12th Road South
Hi-tech Industrial Park
Nanshan 518057 CN
Other 510(k) Applications for this Company
Contact Zhang Wei
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 06/22/2020
Decision Date 08/21/2020
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