GRAPHIC CONTROLS PROTRACE ECG ELECTRODE

Electrode, Electrocardiograph

GRAPHIC CONTROLS CORP.

The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Graphic Controls Protrace Ecg Electrode.

Pre-market Notification Details

Device IDK950485
510k NumberK950485
Device Name:GRAPHIC CONTROLS PROTRACE ECG ELECTRODE
ClassificationElectrode, Electrocardiograph
Applicant GRAPHIC CONTROLS CORP. PO BOX 1274 189 VAN RENSSELAER STREET Buffalo,  NY  14240
ContactIgnaty Gusakov
CorrespondentIgnaty Gusakov
GRAPHIC CONTROLS CORP. PO BOX 1274 189 VAN RENSSELAER STREET Buffalo,  NY  14240
Product CodeDRX  
CFR Regulation Number870.2360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-06
Decision Date1995-07-07

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