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510(k) Data Aggregation

    K Number
    K202913
    Device Name
    NeuroCap (Model DEC22)
    Manufacturer
    Date Cleared
    2021-03-05

    (157 days)

    Product Code
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    Memory MD Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NeuroCap (Model DEC22) is an Electroencephalogram (EEG) electrode array intended for use in routine clinical and research settings where recording of STAT EEGs is desired.
    Device Description
    NeuroCap is a disposable electrodes system made of polycarbonate-based film with applied conductive paths and sensors. Each Ag/AgCl sensor is equipped with a sponge that is coated with a conductive gel for providing sensor contact with the scalp (cutaneous) surface. NeuroCap is fixed on the patient by means of adhesive tape and Velcro. NeuroCap could be connected to a signal amplifier directly or via a special adapter. (The adapter will not be included in the subject device.) The practical application of the NeuroCap is in electroencephalography. The NeuroCap disposable electrode system has 19 active channels. The headband of the device is nonsterile and disposable for single patient use. The NeuroCap is designed to be used with the Neuro EEG Device (K173460) for EEG acquisition and recording. The Neuro EEG Device is sold separately. NeuroCap is intended for prescription use in healthcare facilities or clinical research environments. NeuroCap is not intended for current stimulation and must be used by qualified personnel.
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    K Number
    K172866
    Device Name
    NeuroCap
    Manufacturer
    Date Cleared
    2018-04-27

    (219 days)

    Product Code
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    Memory MD INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NeuroCap (model DEC18) is an Electroencephalogram (EEG) electrode array intended for use in ER (emergency room), ICU (intensive care unit) and OR (operating room) for recording of STAT EEGs in patients of 18 years of age and older.
    Device Description
    The NeuroCap (model DEC18) is an Electroencephalogram (EEG) electrode array intended for use in ER (emergency room), ICU (intensive care unit) and OR (operating room) for recording of STAT EEGs in patients of 18 years of age and older. NeuroCap is intended for use with amplifiers of medical signals equipped with appropriate plug or by special adapter will not be included in subject device). NeuroCap is a disposable electrodes system made of polycarbonate based film with applied conductive paths and sensors. Each sensor is equipped with a sponge with a conductive gel for providing sensor contact with the skin surface. NeuroCap is fixed on the patient by means of adhesive tape. NeuroCap could be connected to amplifier directly or via a special adapter. The NeuroCap disposable electrode system is 16 channels. The headband is non-sterile and disposable for single patient use and designed to be used with the Neuro EEG device (K173460) for EEG acquisition and recording. NeuroCap is intended for prescription use in healthcare facilities, or clinical research environments.
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