BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)

    K Number: K240271 · Decision Sep 11, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    174
    Applicant Total
    2
    Review Days
    224

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    Basic Information

    Device Name
    Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
    K Number
    K240271
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Linshom Medical, Inc.
    Date Received
    January 31, 2024
    Decision Date
    September 11, 2024
    Product Code
    BZQ
    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
    BZQ Monitor, Breathing Frequency

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    Other Clearances by Linshom Medical, Inc.

    K Number Device Name
    K250093 Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)