BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Passport Series Patient Monitors(Passport 12m, Passport 17m)

    K Number: K170876 · Decision Aug 23, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    411
    Applicant Total
    16
    Review Days
    152

    Basic Information

    Device Name
    Passport Series Patient Monitors(Passport 12m, Passport 17m)
    K Number
    K170876
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Mindray Bio-medical Electronics Co., LTD.
    Date Received
    March 24, 2017
    Decision Date
    August 23, 2017
    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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