F40 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 40MM

Electrode, Electrocardiograph

S & W MEDICO TEKNIK

The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for F40 K Karaya Gum Disp. Pe-foam Ecg Electrode, 40mm.

Pre-market Notification Details

Device IDK884981
510k NumberK884981
Device Name:F40 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 40MM
ClassificationElectrode, Electrocardiograph
Applicant S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark,  DK
ContactLisbeth Isbrandt
CorrespondentLisbeth Isbrandt
S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark,  DK
Product CodeDRX  
CFR Regulation Number870.2360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-11-29
Decision Date1989-03-10

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