BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    ULTIMA SNORING MIKE, MODEL 0540

    K Number: K020312 · Decision Aug 7, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    160
    Applicant Total
    8
    Review Days
    189

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    Basic Information

    Device Name
    ULTIMA SNORING MIKE, MODEL 0540
    K Number
    K020312
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Braebon Medical Corp.
    Date Received
    January 30, 2002
    Decision Date
    August 7, 2002
    Product Code
    MNR
    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
    MNR Ventilatory Effort Recorder

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