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

    PULMOTRACK,MODEL 1010

    K Number: K980878 · Decision Dec 28, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    25
    Applicant Total
    1
    Review Days
    294

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    Basic Information

    Device Name
    PULMOTRACK,MODEL 1010
    K Number
    K980878
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1900
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Karmel Medical Acoustic Technologies , Ltd.
    Date Received
    March 9, 1998
    Decision Date
    December 28, 1998
    Product Code
    BZM
    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
    BZM Calculator, Pulmonary Function Interpretor (Diagnostic)

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