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510(k) Data Aggregation

    K Number
    K173170
    Device Name
    Epicardia Anywhere
    Manufacturer
    Medicomp, Inc.
    Date Cleared
    2018-01-10

    (103 days)

    Product Code
    DSI
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medicomp, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Epicardia Anywhere is indicated as a screening tool for patients who require ambulatory ECG monitoring for extended time periods. The system records and analyzes the patient's ECG, and provides various summary reports that detail any clinically-significant events the patient may have had, based on the Epicardia Anywhere classifications. These reports are then reviewed, revised if necessary by a trained operator and then confirmed by a qualified clinician.
    Device Description
    The Epicardia Anywhere System is a screening tool for patients who require ambulatory ECG monitoring for extended time periods. The system records and analyzes the patient's ECG, and provides various summary reports that detail and clinicallysignificant events the patient may have had, based on the Epicardia Anywhere classifications. These reports are then reviewed, revised if necessary by a trained operator and then confirmed by a qualified clinician.
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    K Number
    K161916
    Device Name
    TelePatch Cardiac Monitor
    Manufacturer
    MEDICOMP, INC.
    Date Cleared
    2016-12-21

    (162 days)

    Product Code
    DRG, MLO
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICOMP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TelePatch Cardiac Monitor PM750, is a pager-sized, handheld or patient worn device designed specifically to record and transmit ambulatory ECG signals. The device is designated as Rx only, to be worn by infants to adults of all ages. The device can be worn for days or weeks, as it is intended for use by patients who are experiencing symptoms that are transient and infrequent in nature.
    Device Description
    TelePatch Cardiac Monitor PM750 is a small, auto triggered, device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia. Shortness of breath and palpations are examples of these symptoms. This device may be worn for a period of days or weeks - whatever time is necessary to capture and record the ECG. The PM750 has two operating modes to allow for event analysis of the recorded ECG or in Holter mode to allow for full disclosure analysis of the recorded ECG. The device is comprised of the function contained within the CardioPAL SAVI (Model PM410) ECG loop recorder and the SAVI Wireless (Model PM500) event monitor and an off the shelf cellular phone. The device can be used with a break-away lanyard and has interaction with a PC interface cable.
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    K Number
    K091696
    Device Name
    SAVI WIRELESS, MODEL PM500
    Manufacturer
    MEDICOMP, INC.
    Date Cleared
    2009-10-26

    (138 days)

    Product Code
    DRG
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICOMP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SAVI Wireless PM500, is a pager-sized, handheld or patient worn device designed specifically to record and transmit ambulatory ECG signals. The device can be worn for days or weeks, as it is intended for use by patients who are experiencing symptoms that are transient and infrequent in nature.
    Device Description
    The SAVI Wireless Model PM500, is a small, auto triggered, hand-held device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia. Shortness of breath and palpitations are examples of these symptoms. This device may be worn for a period of days or weeks - whatever time is necessary to capture and record the ECG. The device consists of the SAVI Wireless event monitor, patient cable, and off the shelf cellular telephone. The device can be used with accessories, including a belt clip, lanyard, and PC interface cable.
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    K Number
    K090834
    Device Name
    EPICARDIA 5000
    Manufacturer
    MEDICOMP, INC.
    Date Cleared
    2009-05-15

    (49 days)

    Product Code
    DSI
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICOMP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Epicardia 50000 system is indicated as a screening tool for patients who require ambulatory EDG montaring for extended time periods. The system rocarde and analyzes the cation's ECG, and provides various summary reports that detail any clinically-significant events the patient may have had, based on the EPICARDIA classifications. These reports are then reviewed, revised If nocessary by a trained operator and then confirmed by a qualified oliniolan.
    Device Description
    The EPICARDIA System is a screening tool for patients who require ambulatory ECG monitoring for extended time periods. The system records and analyzes the patient's ECG, and provides various summary reports that detail any clinically-significant events the patient may have had, based on the EPICARDIA classifications. These reports are then reviewed, revised if necessary by a trained operator and then confirmed by a qualified clinician.
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    K Number
    K043454
    Device Name
    CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410
    Manufacturer
    MEDICOMP, INC.
    Date Cleared
    2005-03-24

    (99 days)

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

    MEDICOMP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CardioPAL A1 with Diogenes SV (CardioPal SV) Model PM410, is a pager-sized, hand-held or patient worn device designed specifically to record and transmit ambulatory ECG signals. The device can be worn for days or weeks, as it is intended for use by patients who are experiencing symptoms that are transient and infrequent in nature.
    Device Description
    The CardioPAL AI with Diogenes SV (CardioPAL SV) Model PM410, is a small, auto triggered, hand-held device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia. Shortness of breath and palpitations are examples of these symptoms. This device may be worn for a period of days or weeks – whatever time is necessary to capture and record the ECG. The device consists of the CardioPAL SV event monitor and patient cable. The device can be used with accessories, including a belt clip, lanyard, and PC interface cable.
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    K Number
    K981119
    Device Name
    CARDIOPAL MODEL NUMBER PM20
    Manufacturer
    MEDICOMP, INC.
    Date Cleared
    1998-10-14

    (201 days)

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

    MEDICOMP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CardioPAL is a pager-sized, handheld or patient-worn device designed specifically to record and transmit ambulatory ECG signals. The device can be worn for days or weeks, as it is intended for use by patients who are experiencing symptoms that are transient and infrequent in nature. Since the CardioPAL is patient-activated, the device is not intended for use by patients who are unable to activate the Record switch when they are experiencing a symptom.
    Device Description
    The CardioPAL is a pager-sized, handheld or patient-worn device designed specifically to record and transmit ambulatory ECG signals.
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