Microscope Navigation

Neurological Stereotaxic Instrument

Brainlab AG

The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Microscope Navigation.

Pre-market Notification Details

Device IDK190250
510k NumberK190250
Device Name:Microscope Navigation
ClassificationNeurological Stereotaxic Instrument
Applicant Brainlab AG Olof-Palme-Str. 9 Munich,  DE
ContactAlexander Schwiersch
CorrespondentHugo Morales
Brainlab AG Olof-Palme-Str. 9 Munich,  DE
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-07
Decision Date2019-09-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056481142537 K190250 000

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