BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    HORIZON XVU

    K Number: K081484 · Decision Jun 20, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    21
    Review Days
    23

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    Basic Information

    Device Name
    HORIZON XVU
    K Number
    K081484
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mennen Medical , Ltd.
    Date Received
    May 28, 2008
    Decision Date
    June 20, 2008
    Product Code
    DQK
    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
    DQK Computer, Diagnostic, Programmable

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    Other Clearances by Mennen Medical , Ltd.

    K Number Device Name
    K141441 MENNTOR X7
    K131789 CEREBRALOGIK- AEEG
    K123792 HORIZON XVU (FFR)
    K093766 VITALOGIK 6000/6500
    K091165 HORIZON XVU
    K083063 BIS INTERFACE FOR VITALOGIK PATIENT MONITORS
    K073140 VITALOGIK MODEL 4000/4500
    K071899 BIS MODULE FOR ENVOY PATIENT MONITOR
    K071348 EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM
    K070254 HORIZON SE
    Search all 21 clearances from Mennen Medical , Ltd. →