The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Kolibri Image Guided Surgery System.
| Device ID | K042391 |
| 510k Number | K042391 |
| Device Name: | KOLIBRI IMAGE GUIDED SURGERY SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | BRAINLAB AG AMMERTHALSTRASSE 8 Heimstetten, DE 85551 |
| Contact | Jens Witte |
| Correspondent | Jens Witte BRAINLAB AG AMMERTHALSTRASSE 8 Heimstetten, DE 85551 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-02 |
| Decision Date | 2004-10-19 |
| Summary: | summary |