The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Stereotactic Target Positioner, Target Positioner For Leksell Headring, Stereotactic Counterweight.
| Device ID | K073018 |
| 510k Number | K073018 |
| Device Name: | STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHT |
| Classification | Accelerator, Linear, Medical |
| Applicant | BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Contact | Rainer Birkenbach |
| Correspondent | Rainer Birkenbach BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-25 |
| Decision Date | 2008-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481004118 | K073018 | 000 |
| 04056481004101 | K073018 | 000 |