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510(k) Data Aggregation

    K Number
    K970603
    Device Name
    D SERIES ELECTRODE
    Manufacturer
    CMC SENSE-IT, INC.
    Date Cleared
    1997-04-01

    (42 days)

    Product Code
    DSB
    Regulation Number
    870.2770
    Why did this record match?
    Applicant Name (Manufacturer) :

    CMC SENSE-IT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K963159
    Device Name
    CONDUCTIVE HYDROGEL POLYMER BASED ON U & C SERIES ELECTRODES
    Manufacturer
    CMC SENSE-IT, INC.
    Date Cleared
    1996-12-11

    (119 days)

    Product Code
    DRX
    Regulation Number
    870.2360
    Why did this record match?
    Applicant Name (Manufacturer) :

    CMC SENSE-IT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K955815
    Device Name
    G3000 OR AG2000; DISPOSABLE RESTING ELECTRODE
    Manufacturer
    CMC SENSE-IT, INC.
    Date Cleared
    1996-07-23

    (210 days)

    Product Code
    DRX
    Regulation Number
    870.2360
    Why did this record match?
    Applicant Name (Manufacturer) :

    CMC SENSE-IT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K955800
    Device Name
    SI2000 (SENSE-IT TRADEMARK) OR G2000; DISPOSABLE RESTING ELECTRODE
    Manufacturer
    CMC SENSE-IT, INC.
    Date Cleared
    1996-05-17

    (147 days)

    Product Code
    DRX
    Regulation Number
    870.2360
    Why did this record match?
    Applicant Name (Manufacturer) :

    CMC SENSE-IT, INC.

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

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