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510(k) Data Aggregation

    K Number
    K990027
    Device Name
    OMNICORDER, MODEL 464
    Manufacturer
    Date Cleared
    1999-02-09

    (35 days)

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

    DEL MAR AVIONICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Del Mar Avionics Model 464 OmniCorder™ is intended for use as a Holter ECG cardiac-monitoring tool.
    Device Description
    The Model 464 OmniCorder™ is a compact Holter ECG magnetic tape recorder utilizing standard C60 and C90 cassettes. The recorder may be used to record 2 channel ECG, 3 channel ECG, or 2 channel ECG + pseudo pacer pulses. A fourth track on the tape records a timing track for synchronized playback. Recording may be preset to a tape speed of .75 mm/sec, 1.0 mm/sec or 1.5 mm/sec. Amplitude may be preset to full or half gain. A patient event button records patient items of note on tape while maintaining the ECG signal.
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    K Number
    K971696
    Device Name
    SENTINEL RECORDER, MODELS 471/472
    Manufacturer
    Date Cleared
    1997-12-30

    (236 days)

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

    DEL MAR AVIONICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Del Mar Avionics Models 471/472 Sentinel Recorders are ambulatory Electrocardlographic (ECG) recorders intended to acquire multiple brief episodes of ECG Information. Acquisition of ECG information is initiated by the patient, normally in response to encountered symptoms. The Model 471 Sentinel Recorder acquires a single channel of FCG. The Model 472 Sentinel Recorder acquires one or two channels of ECG. The Models 471 and 472 Sentinel Recorders are intended to be used as an ECG Cardiac Monitoring Instrument.
    Device Description
    Models 471/472 Sentinel ™ Recorders
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    K Number
    K963174
    Device Name
    HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)
    Manufacturer
    Date Cleared
    1997-03-13

    (211 days)

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

    DEL MAR AVIONICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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