GRAPHIC CONTROLS BIOTAC ECO 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 Biotac Eco Electrode.

Pre-market Notification Details

Device IDK950488
510k NumberK950488
Device Name:GRAPHIC CONTROLS BIOTAC ECO 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 Date1995-07-03

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