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

    DORNIR LC-1 CPAP SYSTEM

    K Number: K010704 · Decision Apr 18, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    449
    Applicant Total
    2
    Review Days
    40

    Basic Information

    Device Name
    DORNIR LC-1 CPAP SYSTEM
    K Number
    K010704
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    PRYM MEDICAL LTD.
    Date Received
    March 9, 2001
    Decision Date
    April 18, 2001
    Product Code
    BZD
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BZD Ventilator, Non-Continuous (Respirator)

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