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 K102104
Device Name GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
Applicant
WIPRO GE HEALTHCARE PRIVATE, LTD.
9900 INNOVATION DRIVE
WWAUWATOSA,  WI  53236
Applicant Contact BRYAN BEHN
Correspondent
WIPRO GE HEALTHCARE PRIVATE, LTD.
P.O.Box 7550
Madison,  WI  53707
Correspondent Contact Monica Morrison
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received07/27/2010
Decision Date 10/01/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-