BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA

Electrode, Electrocardiograph

MEDICOTEST A/S

The following data is part of a premarket notification filed by Medicotest A/s with the FDA for Blue Sensor, Disposable Ecg Electrodes For Anaesthesia.

Pre-market Notification Details

Device IDK020382
510k NumberK020382
Device Name:BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA
ClassificationElectrode, Electrocardiograph
Applicant MEDICOTEST A/S 1800 MASSCHUSETTS AVE., N.W. SUITE 200 Washington,  DC  20036 -1221
ContactEmalee G Murphy
CorrespondentEmalee G Murphy
MEDICOTEST A/S 1800 MASSCHUSETTS AVE., N.W. SUITE 200 Washington,  DC  20036 -1221
Product CodeDRX  
CFR Regulation Number870.2360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-05
Decision Date2002-06-28

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