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

    Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17

    K Number: K221616 · Decision Aug 1, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    424
    Applicant Total
    3
    Review Days
    59

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    Basic Information

    Device Name
    Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17
    K Number
    K221616
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Caf Medical Solutions, Inc.
    Date Received
    June 3, 2022
    Decision Date
    August 1, 2022
    Product Code
    MHX
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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    Other Clearances by Caf Medical Solutions, Inc.

    K Number Device Name
    K221879 Patient Monitor, models LM-8, LM-10, LM-12 and LM-15
    K220362 LE-12CH