Software, Sleepware G3 (Japan Only)

Software, Sleepware G3 (Japan Only)
Sleepware - Sleepware G3 Software, (Japan Only) - 3

A mains electricity (AC-powered) device designed to record and interpret a variety of physiologic functions during sleep to evaluate sleep/sleep-related disorders (e.g., insomnia, hypersomnia, apnoea). It typically performs electroencephalography, electrocardiography, electro-oculography, electromyography, and respiration, temperature, and pulse oximetry readings. It may also provide audiovisual information about the sleeping patient for behavioral analysis and other measurements (e.g., gastric reflux, bedwetting). The device includes electrodes, measuring instruments, samplers, filters, amplifiers, and appropriate software for processing data and providing patient diagnoses.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OLZ

Device Name: Automatic Event Detection Software For Polysomnograph With Electroencephalograph

Device Class: 2

Physical State: Electroencephalograph analysis software. Does NOT include electrodes, electroencephalograph hardware, polysomnograph hardware, or basic electroencephalograph/polysomnograph software (e.g. used to display, store, archive, or manually annotate data).

Definition: Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified user

Submission Type ID: 1

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Uses software algorithms to analyze electroencephalograph and polysomnograph waveforms and automatically identify areas of interest to the user

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Brain

Regulation Number: 882.1400

Third Party Flag: N

Medical Specialty: NE

Device Id: 00606959046955

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A