The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Cranial 4pi Immobilization.
| Device ID | K202050 |
| 510k Number | K202050 |
| Device Name: | Cranial 4Pi Immobilization |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-24 |
| Decision Date | 2020-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481144241 | K202050 | 000 |
| 04056481141936 | K202050 | 000 |
| 04056481141943 | K202050 | 000 |
| 04056481141950 | K202050 | 000 |
| 04056481144180 | K202050 | 000 |
| 04056481144197 | K202050 | 000 |
| 04056481144203 | K202050 | 000 |
| 04056481144210 | K202050 | 000 |
| 04056481144227 | K202050 | 000 |
| 04056481144234 | K202050 | 000 |
| 04056481141363 | K202050 | 000 |