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 K171926
Device Name C5 Diagnostic Ultrasound System
Applicant
Guangzhou Sonostar Technologies Co., Ltd.
504#, C Bldg.,#27 Yayingshi Rd., Science Town
Guangzhou,  CN 510665
Applicant Contact Weizhong Cai
Correspondent
Wenzhou Cytech Information Service Co., Ltd.
Rm.302, #21 Bldg., Kaiyu Garden, Xishan S. Rd.
Wenzhou,  CN 325000
Correspondent Contact Helen Nan
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received06/27/2017
Decision Date 10/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-