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

    FIRSTSAVE BIPHASIC MODEL #9200 AND 9210

    K Number: K010214 · Decision Feb 22, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    227
    Applicant Total
    7
    Review Days
    30

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    Basic Information

    Device Name
    FIRSTSAVE BIPHASIC MODEL #9200 AND 9210
    K Number
    K010214
    Device Class
    FDA class 3
    Clearance Type
    Special
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Survivalink Corp.
    Date Received
    January 23, 2001
    Decision Date
    February 22, 2001
    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 Survivalink Corp.

    K Number Device Name
    K011901 FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200
    K993072 SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630)
    K982264 FIRSTSAVE BIPHASIC MODELS 9200 AND 9210
    K970481 V2
    K971149 SVL-9130 DEFIBRILLATION ELECTRODE
    K940445 VIVALINK AED DEFIBRILLATOR