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

    BIOHARNESS

    K Number: K113045 · Decision Aug 14, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    424
    Applicant Total
    4
    Review Days
    306

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    Basic Information

    Device Name
    BIOHARNESS
    K Number
    K113045
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zephyr Technology Corporation
    Date Received
    October 13, 2011
    Decision Date
    August 14, 2012
    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 Zephyr Technology Corporation

    K Number Device Name
    K122763 PHYSIOLOGICAL DATA PROCESSOR
    K123658 BIOMODULE 3-M1
    K100040 BIOHARNESS