Cranial EM System

Neurological Stereotaxic Instrument

Brainlab AG

The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Cranial Em System.

Pre-market Notification Details

Device IDK213989
510k NumberK213989
Device Name:Cranial EM System
ClassificationNeurological Stereotaxic Instrument
Applicant Brainlab AG Olof-Palme-Str. 9 Munich,  DE 81829
ContactChiara Cunico
CorrespondentChiara Cunico
Brainlab AG Olof-Palme-Str. 9 Munchen,  DE 81829
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-20
Decision Date2022-09-08

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