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510(k) Data Aggregation
K Number
K053112Device Name
BIOSIGN
Manufacturer
OXFORD BIOSIGNALS LIMITED
Date Cleared
2006-01-31
(88 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
OXFORD BIOSIGNALS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BioSign™ is an accessory to a multi-parameter patient monitor (bedside or ambulatory) or clinical information system and is indicated for use by health care professionals with those non-pediatric high dependency care patients for whom multi-parameter patient monitoring has been routine.
BioSign™ provides the clinician with a trend graph of the patient status index based on a weighted average of five vital signs namely heart rate, respiration rate, temperature, oxygen saturation and blood pressure. The patient status index is a single measure of the patient's condition and represents how different the patient's vital signs are with respect to normality. BioSign™ is an adjunct to and is not intended to replace vital signs monitoring.
Device Description
BioSign™ is a software accessory to standard multiple parameter physiological patient monitors (bedside or ambulatory) or clinical information systems. It operates on a standard medical grade computer.
BioSign™ is a software device embedded in a standard medical grade computer that through advanced signal processing can combine physiological signals in order to produce a single graph representation of patient condition.
BioSign™ is a computerized analysis system that can accept multiple channels of physiological data (for example heart rate, respiratory rate, temple viauncis of pressure and oxygen saturation as inputs). Through advanced signal procession, BioSign can identify changes in patient status.
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K Number
K042309Device Name
BIOSOMNIA-V3
Manufacturer
OXFORD BIOSIGNALS LIMITED
Date Cleared
2004-09-08
(14 days)
Product Code
OMC, OLV
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
OXFORD BIOSIGNALS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Oxford BioSignals BioSomnia V3 is a three channel ambulatory device providing signal amplification of two channels of EEG and one of EMG and connections to external devices for subsequent EEG / EMG signal display, storage and analysis. The device is designed to be used overnight in the patient's home environment to assist the physician in diagnosing sleep disorders.
Device Description
Oxford BioSignals BioSomnia V3 is a three channel ambulatory device providing signal amplification of two channels of EEG and one of EMG and connections to external devices for subsequent EEG / EMG signal display, storage and analysis.
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K Number
K021485Device Name
BIOSOMNIA
Manufacturer
OXFORD BIOSIGNALS LIMITED
Date Cleared
2002-09-11
(126 days)
Product Code
OMC, OLV
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
OXFORD BIOSIGNALS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Oxford BioSignals BioSomnia is a single channel ambulatory EEG with a software package designed for use as an adjunct for the physician in their diagnosis of sleep disorders and to quantify sleep and wakefulness on a second by second basis.
The device is designed to be used overnight in the patient's home environment to assist the physician in diagnosing sleep disorders.
Device Description
a single channel ambulatory EEG with a software package
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K Number
K002622Device Name
BIOSLEEP
Manufacturer
OXFORD BIOSIGNALS LIMITED
Date Cleared
2000-10-23
(61 days)
Product Code
OLZ
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
OXFORD BIOSIGNALS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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