The following data is part of a premarket notification filed by Vision Rt Limited with the FDA for Gatect-rt.
Device ID | K072171 |
510k Number | K072171 |
Device Name: | GATECT-RT |
Classification | Accelerator, Linear, Medical |
Applicant | VISION RT LIMITED 1244 FAIRWAY VALLEY COURT Lincoln, CA 95648 |
Contact | Robert J Morton, M.s. |
Correspondent | Robert J Morton, M.s. VISION RT LIMITED 1244 FAIRWAY VALLEY COURT Lincoln, CA 95648 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-08-06 |
Decision Date | 2007-10-01 |
Summary: | summary |