VV FLUORO 3D

Neurological Stereotaxic Instrument

BRAINLAB AG

The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Vv Fluoro 3d.

Pre-market Notification Details

Device IDK070106
510k NumberK070106
Device Name:VV FLUORO 3D
ClassificationNeurological Stereotaxic Instrument
Applicant BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen,  DE 85622
ContactRainer Birkenbach
CorrespondentRainer Birkenbach
BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen,  DE 85622
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-11
Decision Date2007-04-23
Summary:summary

NIH GUDID Devices

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