BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇦 Canada

    MY01 Continuous Compartmental Pressure Monitor

    K Number: K251900 · Decision Jan 16, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    14
    Applicant Total
    6
    Review Days
    210

    Basic Information

    Device Name
    MY01 Continuous Compartmental Pressure Monitor
    K Number
    K251900
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MY01, Inc.
    Date Received
    June 20, 2025
    Decision Date
    January 16, 2026
    Product Code
    LXC
    Advisory Committee
    Unknown
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LXC Monitor, Pressure, Intracompartmental

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    Other Clearances by MY01, Inc.

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