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510(k) Data Aggregation

    K Number
    K032200
    Device Name
    ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH
    Manufacturer
    REMCO ITALIA S.P.A.
    Date Cleared
    2003-10-03

    (77 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMCO ITALIA S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ELAN® is a digital 12 channel electrocardiograph designed for acquisition and digitization of conventional diagnostic 12-lead simultaneous ECG waveforms and ECG data and real-time visualization of 1 to 6 leads on its built-in LCD monitor. ELAN® can also record and store in its internal memory up to 100 ECG tests. Each ECG test can be analyzed, printed on the internal thermal printer and/or sent to a PC via serial cable, LAN or modem. ELAN® can perform automatic measurements of ECG waveform and preliminary interpretation of ECG test; measurements and diagnostic statements are offered to the physician on an advisory basis only; the physician is asked to review and validate or change the ECG interpretation.
    Device Description
    ELAN® is a digital 12 channel electrocardiograph for the simultaneous acquisition of the 12 ECG leads, featuring 6-lead LCD screen, alphanumeric keyboard and high resolution thermal printer on 210 mm paper. ELAN ® can record and store in its internal memory up to 100 ECG tests. Each ECG test can include patient data, ECG measurements, automatic interpretation, physician report. Stored ECG tests can be reviewed, printed on the internal thermal printer and/or sent to a local or remote PC via serial cable, LAN network or external standard modem.
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    K Number
    K032276
    Device Name
    CLICK HOLTER
    Manufacturer
    REMCO ITALIA S.P.A.
    Date Cleared
    2003-08-27

    (35 days)

    Product Code
    MWJ
    Regulation Number
    870.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMCO ITALIA S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Click Holter recorder is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below: a) Evaluation of symptoms suggesting arrhythmia or myocardial ischemia. b) Evaluation of ECG documenting therapeutic interventions in individual patients or group of patients. c) Evaluation of patient's ST segment alterations. d) Patient follow up after M.I. or cardiac surgery. e) Clinical and epidemiological studies f) Pace maker evaluation g) Time or Frequency domain heart rate variability analysis h) Qt interval analysis
    Device Description
    Click Holter is a personal three channels Ambulatory ECG recorder characterized by the following features: - Up to 48 hours continuous ECG recording on three independent leads - USB port for fast download of recorded data - Possibility to store patient data in the recorder via USB port
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