Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name system, imaging, pulsed doppler, ultrasonic
510(k) Number K152543
Device Name M9/M9CV/M9T Diagnostic Ultrasound System
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd
Keji 12th Road South, Hi-tech Industrial Park, Nanshan
HI-TECH INDUSTRIAL PARK, NANSHAN
shenzhen,  CN 518057
Applicant Contact wu zicui
Correspondent
Shenzhen Mindray Bio-Medical Electronics Co., Ltd
Keji 12th Road South, Hi-tech Industrial Park, Nanshan
shenzhen,  CN 518057
Correspondent Contact wu zicui
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received09/04/2015
Decision Date 10/29/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-