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 Transducer, Ultrasonic, Diagnostic
510(k) Number K101008
Device Name DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY
Applicant
Shantou Institute of Ultrasonic Instruments (Siui
7263 Cronin Cir.
Dublin,  CA  94568
Applicant Contact BOB LEIKER
Correspondent
Shantou Institute of Ultrasonic Instruments (Siui
7263 Cronin Cir.
Dublin,  CA  94568
Correspondent Contact BOB LEIKER
Regulation Number892.1570
Classification Product Code
ITX  
Subsequent Product Codes
IYN   IYO  
Date Received04/12/2010
Decision Date 06/08/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-