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510(k) Data Aggregation
K Number
K111314Device Name
MORPHEUS OX
Manufacturer
WIDEMED LTD
Date Cleared
2011-08-31
(113 days)
Product Code
MNR, VEN
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
WIDEMED LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Morpheus Ox Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid in the detection of Chevne-Stokes Respiration (CSR), and to estimate Apnea Hypopnea Index (AHI), in a Cardiac patient population that is suspected of having Sleep Disordered Breathing (SDB). The Morpheus Ox System is intended to be used for analysis, display, redisplay (retrieve), reports generation and networking of physiological data received from an oximeter device. It does not perform automatic classification of respiratory events as central or obstructive. This system is to be used under the supervision of a physician.
Morpheus Ox displays heart rate, saturation and photoplethysmograph signals, acquired from an oximeter device. Morpheus Ox may also display signals including: EtCO2, Respiratory impedance, Plethysmograph Derived Respiratory (PDR) calculated signal, Activity, ECG, EEG, P flow, C flow, EMG, EOG, Snore, Leg movement, Abdomen, Thorax, EPAP, IPAP.
Device Description
The Morpheus Ox Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid in the detection of Cheyne-Stokes Respiration (CSR), and to estimate Apnea Hypopnea Index (AHI), in a Cardiac patient population that is suspected of having Sleep Disordered Breathing (SDB).
The Morpheus Ox System is designed to process the raw signal data acquired by an oximeter device in standard medical download format, analyze them, obtain the study's analysis results, generate summary reports, and display the signals' data and reports on a personal computer, using a standard Internet Explorer Browser.
Signals from the oximeter device include the following:
- o Saturation
- o Photoplethysmograph signal
Scoring analysis and display includes:
- O Cheyne-Stokes Respiration (CSR)
- 0 Apnea/Hypopnea Index (AHI)
- o Display of acquired signals such as EtCO2, Respiratory impedance, Photoplethysmograph Derived Respiratory (PDR) calculated signal, ECG, EEG, P flow, T flow, C flow, EMG, EOG, Snore, Leg movement, Abdomen, Thorax, EPAP, IPAP, and Heart rate.
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K Number
K070326Device Name
NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM
Manufacturer
WIDEMED LTD
Date Cleared
2007-05-05
(89 days)
Product Code
MNR, VEN
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
WIDEMED LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Noga Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid for the diagnosis of respiratory related sleep disorders.
The Noga System is intended to be used for analysis, display, redisplay (retrieve), summarize, reports generation and networking of physiological data received from a physiological activity monitoring device.
Physiological data includes: ECG, SpO2, EtCO2 and Impedance respiration.
Device Description
The Noga Automated Study Scoring and Data Management System (Noga System) is a Web-based computer program (software), intended for use as an aid to the diagnosis of respiratory-related sleep disorders.
The Noga System is designed to process the raw signal data acquired by a third party physiological activity monitoring device in standard medical download format, analyze them, obtain the study's analysis results, generate summary reports, and display the signals' data and reports on a personal computer, using a standard Internet Explorer Browser.
Signals from the physiological activity monitoring device include the following:
- ECG
- Impedance respiration
- EtCO2
- SpO2
Scoring Analysis includes:
- Apnea/Hypopnea Index (AHI)
- Sleep Staging (Sleep - Wake stages, and Total Sleep Time)
- Respiratory Events Detection (Apnea and Hypopnea)
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K Number
K022506Device Name
MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM
Manufacturer
WIDEMED LTD
Date Cleared
2003-05-15
(289 days)
Product Code
MNR
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
WIDEMED LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Morpheus ™ 1 Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory disorders.
The Morpheus ™ 1, Automated Sleep Study Scoring and Data Management System is intended to be used for analysis (automatic scoring and manual re-scoring), display, redisplay (retrieve), summarize, reports generation and networking of data received from monitoring devices typically used to evaluate sleep and respiratory related sleep disorders.
This device is to be used under the supervision of a physician.
Device Description
The Morpheus™ 1, Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory disorders.
The Morpheus 100 1, Automated Sleep Study Scoring and Data Management System is intended to be used for analysis (automatic scoring and manual rescoring), display, redisplay (retrieve), summarize, reports generation and networking of data received from monitoring devices typically used to evaluate sleep and respiratory related sleep disorders.
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