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510(k) Data Aggregation

    K Number
    K060297
    Device Name
    PEPER
    Date Cleared
    2006-08-02

    (177 days)

    Product Code
    Regulation Number
    870.2920
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL MONITORS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The pePER is indicated for use by patients as directed by a physician, who experience transient symptoms that may suggest cardiac arrhythmia, conduction abnormalities or other rhythm disturbances that may result in shortness of breath, pre-syncope or palpitations.
    Device Description
    The pePER is a battery operated transtelephonic ECG event recorder and transmitter that is capable of storing multiple electrocardiograms and the transmission of these recordings by telephone to a receiving system. The pePER stores the ECG after the `record' button is depressed. The recording period is preset up to 40 seconds with 2 recordings stored. The stored ECGs are transmitted by acoustic output by coupling the telephone mouthpiece over the pePER.
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