The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Cranial Image Guided Surgery System.
| Device ID | K082060 |
| 510k Number | K082060 |
| Device Name: | CRANIAL IMAGE GUIDED SURGERY SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Contact | Rainer Birkenbach |
| Correspondent | Rainer Birkenbach BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-21 |
| Decision Date | 2009-05-08 |
| Summary: | summary |