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510(k) Data Aggregation
K Number
K063599Device Name
PORTI 7 PHYSIOLOGICAL AMPLIFIER
Manufacturer
TMS INTERNATIONAL BV
Date Cleared
2007-03-22
(108 days)
Product Code
GWL
Regulation Number
882.1835Why did this record match?
Applicant Name (Manufacturer) :
TMS INTERNATIONAL BV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Porti Physiological Amplifier is intended to be use by or under the directions of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of the signals to a PC during recording of neuro-physical/physiological research and exams.
Polygraphy and polysmnography may besides EEG, include physiological information such as EMG, ECG, EGG, EGG, PH, Respiration, Temperature and Oxygen Saturation.
Device Description
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K Number
K060374Device Name
REFA, PHYSIOLOGICAL AMPLIFIER
Manufacturer
TMS INTERNATIONAL BV
Date Cleared
2006-05-30
(106 days)
Product Code
GWL
Regulation Number
882.1835Why did this record match?
Applicant Name (Manufacturer) :
TMS INTERNATIONAL BV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The REFA Physiological Amplifier family is intended to be used by or under the direction of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of the signals to a PC during recording of neurophysical/ physiological research and exams.
Polygraphy and Polysomnography may besides EEG, include physiological information such as EMG, ECG, EOG, EGG, PH, Respiration, Temperature and Oxygen Saturation.
Device Description
Not Found
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