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510(k) Data Aggregation
K Number
K972122Device Name
DREAM CATCHER
Manufacturer
Date Cleared
1997-08-29
(85 days)
Product Code
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
REST TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Dream Catcher is a headpiece with adjustable mounts for attaching surface electrodes with lead wires, intended for use during various types of EEG testing in which only a subset of the full 10/20 electrode sites are required. This cap is NOT intended for use in which a full set of the 10/20 electrode positions need to be monitored, or in which precise localization of the EEG activity is of vital importance such as localization of a seizure focus. The Dream Catcher holds electrodes at the C3, Cz, C4, O1, OZ, O2, A1 and A2 positions.
Device Description
The Dream Catcher is a headpiece with adjustable mounts for attaching surface electrodes with lead wires.
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