SKINTACT AND VARIOUS OTHER TRADENAMES

Electrode, Electrocardiograph

LEONHARD LANG GMBH

The following data is part of a premarket notification filed by Leonhard Lang Gmbh with the FDA for Skintact And Various Other Tradenames.

Pre-market Notification Details

Device IDK073104
510k NumberK073104
Device Name:SKINTACT AND VARIOUS OTHER TRADENAMES
ClassificationElectrode, Electrocardiograph
Applicant LEONHARD LANG GMBH P.O. BOX 560 Stillwater,  MN  55082 -0560
ContactElaine Duncan
CorrespondentElaine Duncan
LEONHARD LANG GMBH P.O. BOX 560 Stillwater,  MN  55082 -0560
Product CodeDRX  
CFR Regulation Number870.2360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-11-02
Decision Date2007-11-16
Summary:summary

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