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510(k) Data Aggregation

    K Number
    K982034
    Device Name
    E-FAX SYSTEM
    Date Cleared
    1999-02-19

    (254 days)

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

    BLAKBAG, LTD., DIVISION OF COHERENT SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The E-FAX Pacemaker Services software is designed to provide an additional program directory in the E-FAX System to support scheduling, receiving, and annotating transtelephonic pacemaker magnet testing and ECG strips using a pacemaker telephonic transmitter provided to the patient by his/her physician.
    Device Description
    The E-FAX Pacemaker Services software is an add on to the present E-FAX System software (K932859), that provides additional program directory in the E-FAX System to support scheduling, receiving, and annotating transtelephonic pacemaker magnet testing using a pacemaker transmitter provided to the patient by his/her physician.
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