ExacTrac Dynamic
Accelerator, Linear, Medical
Brainlab AG
The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Exactrac Dynamic.
Pre-market Notification Details
| Device ID | K201276 |
| 510k Number | K201276 |
| Device Name: | ExacTrac Dynamic |
| Classification | Accelerator, Linear, Medical |
| Applicant | Brainlab AG Olof-Palme-Str. 9 Munich, DE 81829 |
| Contact | Chiara Cunico |
| Correspondent | Chiara Cunico Brainlab AG Olof-Palme-Str. 9 Munich, DE 81829 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-13 |
| Decision Date | 2020-07-13 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481142506 | K201276 | 000 |
Trademark Results [ExacTrac Dynamic]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXACTRAC DYNAMIC 79224882 5630026 Live/Registered |
Brainlab AG 2017-11-07 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.