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

    BresoDX1

    K Number: K220012 · Decision Dec 21, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    160
    Applicant Total
    1
    Review Days
    351

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    Basic Information

    Device Name
    BresoDX1
    K Number
    K220012
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bresotec, Inc.
    Date Received
    January 4, 2022
    Decision Date
    December 21, 2022
    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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