The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Modification To: Vectorvision Frameless Biopsy System.
| Device ID | K012564 |
| 510k Number | K012564 |
| Device Name: | MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | BRAINLAB AG AMMERTHALSTRASSE 8 Heimstetten, DE 85551 |
| Contact | Stefan Vilsmeier |
| Correspondent | Stefan Vilsmeier BRAINLAB AG AMMERTHALSTRASSE 8 Heimstetten, DE 85551 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-09 |
| Decision Date | 2001-09-06 |
| Summary: | summary |