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

    VIVALINK AED DEFIBRILLATOR

    K Number: K940445 · Decision Feb 9, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    227
    Applicant Total
    7
    Review Days
    373

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    VIVALINK AED DEFIBRILLATOR
    K Number
    K940445
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Survivalink Corp.
    Date Received
    February 1, 1994
    Decision Date
    February 9, 1995
    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)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MKJ), ordered by most recent decision date.

    Powerheart G5 AED

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    OneStep Pediatric CPR Multi-Function Electrode

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    samaritan PAD 450P

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ZOLL E SERIES

    FDA 510(k)
    FDA Class 3 ·Cardiovascular
    View all

    Other Clearances by Survivalink Corp.

    K Number Device Name
    K011901 FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200
    K010214 FIRSTSAVE BIPHASIC MODEL #9200 AND 9210
    K993072 SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630)
    K982264 FIRSTSAVE BIPHASIC MODELS 9200 AND 9210
    K970481 V2
    K971149 SVL-9130 DEFIBRILLATION ELECTRODE