BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SKINTACT

    K Number: K140340 · Decision May 21, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    17
    Review Days
    99

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    Basic Information

    Device Name
    SKINTACT
    K Number
    K140340
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Leonhard Lang GmbH
    Date Received
    February 11, 2014
    Decision Date
    May 21, 2014
    Product Code
    GXY
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GXY Electrode, Cutaneous

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    Other Clearances by Leonhard Lang GmbH

    K Number Device Name
    K142803 Skintact, various other tradenames
    K140500 SKINTACT
    K103186 SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES
    K092291 SKINTACT AND VARIOUS OTHER TRADENAMES
    K081371 SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL
    K080106 SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE
    K073104 SKINTACT AND VARIOUS OTHER TRADENAMES
    K072233 SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS
    K063161 SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL
    K041883 SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21
    Search all 17 clearances from Leonhard Lang GmbH →