IPLAN RT FIBERTRACKING

Accelerator, Linear, Medical

BRAINLAB AG

The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Iplan Rt Fibertracking.

Pre-market Notification Details

Device IDK052220
510k NumberK052220
Device Name:IPLAN RT FIBERTRACKING
ClassificationAccelerator, Linear, Medical
Applicant BRAINLAB AG AMMERTHALSTRASSE 8 Heimstetten,  DE 85551
ContactRainer Birkenbach
CorrespondentRainer Birkenbach
BRAINLAB AG AMMERTHALSTRASSE 8 Heimstetten,  DE 85551
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-15
Decision Date2005-09-30
Summary:summary

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