Hemo Control (optional Add Pack Hemo Control DM)

System, Hemoglobin, Automated

EKF-diagnostic GmbH

The following data is part of a premarket notification filed by Ekf-diagnostic Gmbh with the FDA for Hemo Control (optional Add Pack Hemo Control Dm).

Pre-market Notification Details

Device IDK200909
510k NumberK200909
Device Name:Hemo Control (optional Add Pack Hemo Control DM)
ClassificationSystem, Hemoglobin, Automated
Applicant EKF-diagnostic GmbH Ebendorfer Chaussee 3 Barleben,  DE 39179
ContactAndrew J. Rutter
CorrespondentAndrew J. Rutter
EKF-diagnostic GmbH Ebendorfer Chaussee 3 Barleben,  DE 39179
Product CodeGKR  
CFR Regulation Number864.5620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-06
Decision Date2020-06-12

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