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510(k) Data Aggregation

    K Number
    K243788
    Device Name
    IceCap product line
    Manufacturer
    Bioserenity Medical Devices Group
    Date Cleared
    2025-03-13

    (94 days)

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

    Bioserenity Medical Devices Group

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IceCaps (IceCap 2, IceCap 2 Small, IceCap Neonate (Sizes XS, S, & M)) are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurological disorders with a short or long-term EEG record (up to 72 hours). IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 lbs) and having a head circumference above 43 cm (16.93 inches). IceCap Neonate shall be placed on the head of babies, newborns and premature babies.
    Device Description
    The IceCaps (IceCap 2, IceCap 2 Small, IceCap Neonate (Sizes XS, S, & M)) are medical devices used as EEG electrodes. The IceCaps are a single use cap which connects to the marketed EEG recorders using an IceAdapter or Touchproof adapter. The electrodes placement in IceCap Product line is done accordingly to the 10/20 system. The conductive tracks of the Flexible Printed Circuit are used to conduct EEG signals from the electrodes to the connectors. IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 lbs) and having a head circumference above 43 cm (16.93 inches). IceCap Neonate (M,S,XS) shall be placed on the head of babies, newborns and premature babies.
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