The following data is part of a premarket notification filed by Ge Medical Systems W-400 with the FDA for Seno Advantage.
Device ID | K033400 |
510k Number | K033400 |
Device Name: | SENO ADVANTAGE |
Classification | System, Image Processing, Radiological |
Applicant | GE MEDICAL SYSTEMS W-400 3000 NORTH GRANDVIEW BLVD. Waukesha, WI 53188 |
Contact | Larry A Kroger, Ph.d. |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2003-10-24 |
Decision Date | 2003-12-04 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SENO ADVANTAGE 78322110 3030243 Dead/Cancelled |
General Electric Company 2003-11-03 |