The following data is part of a premarket notification filed by Brainlab, Ag with the FDA for Vectorvision2.
Device ID | K983831 |
510k Number | K983831 |
Device Name: | VECTORVISION2 |
Classification | Neurological Stereotaxic Instrument |
Applicant | 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 | 1998-10-30 |
Decision Date | 1999-05-19 |