BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇮🇪 Ireland

    HEARTSINE SAMARITAN PAD 350P

    K Number: K123881 · Decision Jul 11, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    227
    Applicant Total
    6
    Review Days
    206

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    Basic Information

    Device Name
    HEARTSINE SAMARITAN PAD 350P
    K Number
    K123881
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Heartsine Technologies, Inc.
    Date Received
    December 17, 2012
    Decision Date
    July 11, 2013
    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 Heartsine Technologies, Inc.

    K Number Device Name
    K142709 samaritan PAD 450P
    K052465 REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351
    K042088 SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301
    K041067 HEARTSINE SAMARITAN PAD
    K023854 SAMARITAN AED, MODEL SAM-01