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510(k) Data Aggregation

    K Number
    K042315
    Device Name
    CEREBRAL STATE MONITOR - CSM
    Manufacturer
    DANMETER A/S
    Date Cleared
    2005-01-21

    (148 days)

    Product Code
    OLW, OMC, ORT
    Regulation Number
    882.1400
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    Applicant Name (Manufacturer) :

    DANMETER A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CSM monitor is intended for use in monitoring the hypnotic state of the brain by data acquisition of EEG signals of the anaesthetized or sedated patient in all areas of the hospital.
    Device Description
    The Cerebral State Monitor (CSM) is a non-invasive measurement tool for use by trained healthcare professionals to measure the level of consciousness (LOC) in all areas of the hospital. Based on EEG, an index (CSI) is calculated, which is used in the estimation of LOC. The CSM displays the CSI but does not perform any data interpretation (i.e., all data interpretation is performed by a physician).
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    K Number
    K032954
    Device Name
    ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80
    Manufacturer
    DANMETER A/S
    Date Cleared
    2004-08-09

    (322 days)

    Product Code
    IPF, GZJ
    Regulation Number
    890.5850
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    Applicant Name (Manufacturer) :

    DANMETER A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ELPHA // 500, ELPHA // 1000: This Danmeter device is designed for the symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post-surgical pain and post traumatic acute pain. ELPHA // 2000: This Danmeter device is designed for the relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis and maintaining or increasing range of motion. ELPHA II 3000: This Danmeter device is designed for: - Symptomatic relief and management of chronic (long-term), intractable pain and as an adjunctive treatment in the management of post-surgical pain and post traumatic acute pain. - Relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis and maintaining or increasing range of motion.
    Device Description
    Not Found
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    K Number
    K032955
    Device Name
    AUTOMOVE, MODEL AM800
    Manufacturer
    DANMETER A/S
    Date Cleared
    2003-12-15

    (84 days)

    Product Code
    IPF
    Regulation Number
    890.5850
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    Applicant Name (Manufacturer) :

    DANMETER A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Stroke Rehab by Muscle Reeducation Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Maintaining or increasing range of motion
    Device Description
    Not Found
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    K Number
    K032988
    Device Name
    ELPHA 4 CONTI
    Manufacturer
    DANMETER A/S
    Date Cleared
    2003-12-03

    (70 days)

    Product Code
    KPI
    Regulation Number
    876.5320
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    Applicant Name (Manufacturer) :

    DANMETER A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electrical stimulation of the pelvic floor muscles with the use of vaginal probe. The effect is strengthening the pelvic floor muscles and an activation of the central nervous system. Electrical stimulation of the pelvic floor muscles can reduce urinary incontinence among stress and urge incontinent adult females.
    Device Description
    Not Found
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