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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.

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This document is a 510(k) clearance letter for the Porti 7, a physiological signal amplifier, indicating it is substantially equivalent to legally marketed predicate devices. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. Therefore, I cannot provide the requested information based on the given text.

The document mainly focuses on the regulatory approval process by the FDA, including:

• Device Name: Porti 7
• Regulation Number: 21 CFR 882.1835
• Regulation Name: Physiological signal amplifier
• Regulatory Class: II
• Product Code: GWL
• Indications for Use: Acquisition of EEG, polygraphy, and polysomnography signals and transmission to a PC during recording of neuro-physical/physiological research and exams. This can include physiological information such as EMG, ECG, EGG, pH, Respiration, Temperature, and Oxygen Saturation.

To answer your request, I would need a different document that details the performance study conducted for the Porti 7 and its acceptance criteria.

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