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 K080760
Device Name ACUSON X300 ULTRASOUND SYSTEM
Applicant
Siemens Medical Solutions USA, Inc., Ultrasound DI
1230 Shorebird Way
Mountainview,  CA  94043
Applicant Contact MARTINA VOGT
Correspondent
Siemens Medical Solutions USA, Inc., Ultrasound DI
1230 Shorebird Way
Mountainview,  CA  94043
Correspondent Contact MARTINA VOGT
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
DQO   ITX   IYO  
Date Received03/18/2008
Decision Date 04/25/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-