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

    BIOMONITOR IIIm, BIOMONITOR III

    K Number: K221856 · Decision Jul 27, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    32
    Applicant Total
    85
    Review Days
    30

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    Basic Information

    Device Name
    BIOMONITOR IIIm, BIOMONITOR III
    K Number
    K221856
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biotronik, Inc.
    Date Received
    June 27, 2022
    Decision Date
    July 27, 2022
    Product Code
    MXD
    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
    MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)

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    Other Clearances by Biotronik, Inc.

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    K230375 BIOMONITOR IV
    K222065 Passeo-35 Xeo Peripheral Dilatation Catheter
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