The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Silhouette Vr.
Device ID | K982955 |
510k Number | K982955 |
Device Name: | SILHOUETTE VR |
Classification | System, X-ray, Stationary |
Applicant | GE MEDICAL SYSTEMS P.O. BOX 414 Milwaukee, WI 53201 |
Contact | Larry A Kroger |
Correspondent | Larry A Kroger GE MEDICAL SYSTEMS P.O. BOX 414 Milwaukee, WI 53201 |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-08-24 |
Decision Date | 1998-11-04 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SILHOUETTE VR 78085743 3062035 Dead/Cancelled |
General Electric Company 2001-09-26 |