The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Cranial Em System.
| Device ID | K213989 |
| 510k Number | K213989 |
| Device Name: | Cranial EM System |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | Brainlab AG Olof-Palme-Str. 9 Munich, DE 81829 |
| Contact | Chiara Cunico |
| Correspondent | Chiara Cunico Brainlab AG Olof-Palme-Str. 9 Munchen, DE 81829 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-20 |
| Decision Date | 2022-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481143725 | K213989 | 000 |
| 04056481140410 | K213989 | 000 |
| 04056481004927 | K213989 | 000 |
| 04056481004866 | K213989 | 000 |
| 04056481004811 | K213989 | 000 |
| 04056481144500 | K213989 | 000 |