VECTORVISION CT/FLUORO

Neurological Stereotaxic Instrument

BRAINLAB, AG

The following data is part of a premarket notification filed by Brainlab, Ag with the FDA for Vectorvision Ct/fluoro.

Pre-market Notification Details

Device IDK010968
510k NumberK010968
Device Name:VECTORVISION CT/FLUORO
ClassificationNeurological Stereotaxic Instrument
Applicant BRAINLAB, AG AMMERTHALSTRASSE 8 Heimstetten,  DE 85551
ContactRainer Birkenbach
CorrespondentRainer Birkenbach
BRAINLAB, AG AMMERTHALSTRASSE 8 Heimstetten,  DE 85551
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-02
Decision Date2001-08-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.