BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇭 Switzerland

    Compremium Compartment Compressibility Monitoring System (CPM#1)

    K Number: K223509 · Decision Apr 14, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    143

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    Basic Information

    Device Name
    Compremium Compartment Compressibility Monitoring System (CPM#1)
    K Number
    K223509
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Compremium AG
    Date Received
    November 22, 2022
    Decision Date
    April 14, 2023
    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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