M3 (MIRCO-MULTILEAF COLLIMATOR

Accelerator, Linear, Medical

BRAINLAB AG

The following data is part of a premarket notification filed by Brainlab Ag with the FDA for M3 (mirco-multileaf Collimator.

Pre-market Notification Details

Device IDK004022
510k NumberK004022
Device Name:M3 (MIRCO-MULTILEAF COLLIMATOR
ClassificationAccelerator, Linear, Medical
Applicant BRAINLAB AG AMMERTHALSTRASSE 8 Heimstetten,  DE 85551
ContactStefan Vilsmeier
CorrespondentStefan Vilsmeier
BRAINLAB AG AMMERTHALSTRASSE 8 Heimstetten,  DE 85551
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-12-27
Decision Date2002-03-26

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