Cranial 4Pi Immobilization

Accelerator, Linear, Medical

Brainlab AG

The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Cranial 4pi Immobilization.

Pre-market Notification Details

Device IDK202050
510k NumberK202050
Device Name:Cranial 4Pi Immobilization
ClassificationAccelerator, Linear, Medical
Applicant Brainlab AG Olof-Palme-Str. 9 Munich,  DE 81829
ContactChiara Cunico
CorrespondentChiara Cunico
Brainlab AG Olof-Palme-Str. 9 Munich,  DE 81829
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-24
Decision Date2020-08-19

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