The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Vectorvision Cranial, Vectorvision Spinal, Vectorvision Ent.
Device ID | K003589 |
510k Number | K003589 |
Device Name: | VECTORVISION CRANIAL, VECTORVISION SPINAL, VECTORVISION ENT |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-11-20 |
Decision Date | 2001-05-21 |