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510(k) Data Aggregation
K Number
K012020Device Name
RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC
Manufacturer
NON-INVASIVE MONITORING SYSTEMS, INC.
Date Cleared
2001-08-21
(54 days)
Product Code
DQK
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
NON-INVASIVE MONITORING SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RespiEvents™ is a software package running on a personal computer that is intended to provide analysis of breathing patterns from RespiTrace technology, aid in identifying and classifying apneas, displaying heart rate changes from electrocardiographic waveforms, logging values from pulse oximetry, and displaying signals from physiologic recording devices such as a body position sensor and impedance pneumograph, in the wake and sleeping states as well as activities of daily living.
Device Description
RespiEvents™ is a software analysis program running on a personal computer. RespiEvents™ presents waveforms collected from RespiTrace™ technology-based RespiEvelts "prosents wavelorm" and RespiTrace PT™ and is intended to provide analysis of:
- Breathing patterns from Respitrace™ technology, ● ·
- Aid in identifying and classifying apneas, .
- Displaying heart rate changes from electrocardiographic waveforms, .
- Logging values from pulse oximetry, and .
- Displaying signals from physiologic recording devices .
The purpose of RespiEvents™ software is to capture full fidelity Respitrace™ data on a continuous basis, and to provide playback and analysis of the captured data.
The system presents the information from physiologic recording devices such as a body position sensor and impedance pneumograph, in the wake and sleeping states. The system does not present alarms, alarm functions, or alarm management.
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K Number
K001369Device Name
RESPIEVENTS, VERSION 4.2
Manufacturer
NON-INVASIVE MONITORING SYSTEMS, INC.
Date Cleared
2000-07-26
(86 days)
Product Code
DQK
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
NON-INVASIVE MONITORING SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K942771Device Name
RESPIEVENTS
Manufacturer
NON-INVASIVE MONITORING SYSTEMS, INC.
Date Cleared
1996-02-13
(610 days)
Product Code
DQK
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
NON-INVASIVE MONITORING SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K942852Device Name
RESPITRACE PT
Manufacturer
NON-INVASIVE MONITORING SYSTEMS, INC.
Date Cleared
1996-02-13
(610 days)
Product Code
DQK
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
NON-INVASIVE MONITORING SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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