System, Tomography, Computed, Emission


The following data is part of a premarket notification filed by Miegmbh with the FDA for Ancoris.

Pre-market Notification Details

Device IDK201807
510k NumberK201807
Device Name:ANCORIS
ClassificationSystem, Tomography, Computed, Emission
Applicant MiEGmbH Hauptstrasse 112 Seth,  DE 23845
ContactThomas Kuehl
CorrespondentThomas Kuehl
MiEGmbH Hauptstrasse 112 Seth,  DE 23845
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-01
Decision Date2020-08-27

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