Microscope Navigation Software

Neurological Stereotaxic Instrument

Brainlab AG

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

Pre-market Notification Details

Device IDK172820
510k NumberK172820
Device Name:Microscope Navigation Software
ClassificationNeurological Stereotaxic Instrument
Applicant Brainlab AG Olof-Palme-Str. 9 Munich,  DE
ContactAlexander Schwiersch
CorrespondentAlexander Schwiersch
Brainlab AG Olof-Palme-Str. 9 Munich,  DE
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-18
Decision Date2018-03-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056481140557 K172820 000

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