BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES

    K Number: K103186 · Decision Feb 8, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    227
    Applicant Total
    17
    Review Days
    102

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    Basic Information

    Device Name
    SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES
    K Number
    K103186
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Leonhard Lang GmbH
    Date Received
    October 29, 2010
    Decision Date
    February 8, 2011
    Product Code
    MKJ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MKJ Automated External Defibrillators (Non-Wearable)

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    Other Clearances by Leonhard Lang GmbH

    K Number Device Name
    K142803 Skintact, various other tradenames
    K140500 SKINTACT
    K140340 SKINTACT
    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 →