The following data is part of a premarket notification filed by Brainlab, Ag with the FDA for Vectorvision Spine Module.
| Device ID | K981508 |
| 510k Number | K981508 |
| Device Name: | VECTORVISION SPINE MODULE |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | BRAINLAB, AG 3100 HANSEN WAY Palo Alto, CA 94304 |
| Contact | Stefan Vilsmeier |
| Correspondent | Stefan Vilsmeier BRAINLAB, AG 3100 HANSEN WAY Palo Alto, CA 94304 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-27 |
| Decision Date | 1998-10-29 |