PREGELLED DISPOSABLE E.K.G. ELECTRODE

Electrode, Electrocardiograph

VERMONT MEDICAL, INC.

The following data is part of a premarket notification filed by Vermont Medical, Inc. with the FDA for Pregelled Disposable E.k.g. Electrode.

Pre-market Notification Details

Device IDK781430
510k NumberK781430
Device Name:PREGELLED DISPOSABLE E.K.G. ELECTRODE
ClassificationElectrode, Electrocardiograph
Applicant VERMONT MEDICAL, INC. 9 LOVELL DRIVE Bellows Falls,  VT  05101 -0556
Product CodeDRX  
CFR Regulation Number870.2360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-08-21
Decision Date1978-10-31

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