BLUE 400

Diagnostic Neurosurgical Microscope Filter

Carl Zeiss Meditec AG

The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Blue 400.

Pre-market Notification Details

Device IDK211346
510k NumberK211346
Device Name:BLUE 400
ClassificationDiagnostic Neurosurgical Microscope Filter
Applicant Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 Jena,  DE 07745
ContactHans-Joachim Miesner
CorrespondentMaria Golovina
Carl Zeiss Meditec Inc 5300 Central Parkway Dublin,  CA  94568
Product CodeQFX  
CFR Regulation Number882.4950 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-03
Decision Date2022-07-22

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