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510(k) Data Aggregation
K Number
K201747Device Name
8-CH Electroencephalography Amplifier
Manufacturer
Date Cleared
2020-12-27
(184 days)
Regulation Number
882.1835Why did this record match?
Applicant Name (Manufacturer) :
HippoScreen Neurotech Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The 8-CH Electroencephalography Amplifier is intended to be used by or under the direction of a physician for acquisition of EEG signals, to transmit them digitally to a computer, and display waveform in real-time. The device is intended for use on humans. The device is intended for use in a clinical environment (e.g., hospital, physician's office, etc). The device is not intended for use in life support systems.
Device Description
8-CH Electroencephalography Amplifier capture brain wave signals through non-invasive electrodes, amplify the analog signals and convert to digital signals for computer use. The EEG monitoring panel can immediately display patient's brain wave to assure signal quality of testing requirements. Begin to test when signal quality lamp on EEG monitoring panel shows green light.
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