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510(k) Data Aggregation
K Number
K243788Device Name
IceCap product line
Manufacturer
Bioserenity Medical Devices Group
Date Cleared
2025-03-13
(94 days)
Product Code
GXY
Regulation Number
882.1320Why 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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