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Found 10 results
510(k) Data Aggregation
K Number
K023618Device Name
SONICAID ONE
Manufacturer
OXFORD INSTRUMENTS MEDICAL LTD.
Date Cleared
2003-01-22
(85 days)
Product Code
HGM
Regulation Number
884.2740Why did this record match?
Applicant Name (Manufacturer) :
OXFORD INSTRUMENTS MEDICAL LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sonicaid®One Fetal Heart Detector intended use is designed for early detection of fetal life and confirmation of continued life during pregnancy and labour.
Device Description
Sonicaid® One Fetal Heart Detector
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K Number
K992607Device Name
SONICAID SYSTEM 8002
Manufacturer
OXFORD INSTRUMENTS MEDICAL SYSTEMS
Date Cleared
2001-04-27
(633 days)
Product Code
HGM
Regulation Number
884.2740Why did this record match?
Applicant Name (Manufacturer) :
OXFORD INSTRUMENTS MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sonicaid® System 8002 is for use in pregnancies from 32 weeks gestation and greater. It can be used on women who are experiencing Braxton-Hicks contractions but is not suitable for use in established labour as the fetus is then exposed to additional factors such as labour contractions, pharmacological agents, epidural anaesthesia, and the possibility of fetal infection secondary to ruptured membranes. Typical indications for use include the following:
- previous questionable fetal heart rate recordings or poor obstetric history
- abnormal umbilical blood flow vekveity waveforms
- suspected fotal anomalies
- suspicion of maternal intoxication or assault
- intrauterine growth retardation
- antepartum haemorrhage
- -- uterine pain
- reduced fetal movements
- hypertension or pre-eclampsia
- reduced amniotic fluid volume
The Sonicaid® System 8002 is used as an adjunct to and is not intended to replace or substitute The Someation of ammiotic fluid amount, Doppler evaluations, and/or biophysical profile.
Device Description
The Sonicaid® System 8002 is a software accessory for the computerized analysis of antepartum cardiotocograms (CTGs) in pregnancies from 32 weeks gestation onwards. It informs the clinician whether a CTG meets a number of criteria that are indicative of a normal CTG.
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K Number
K002150Device Name
SONICAID FM820, SONICAID FM830
Manufacturer
OXFORD INSTRUMENTS
Date Cleared
2001-03-09
(235 days)
Product Code
HGM
Regulation Number
884.2740Why did this record match?
Applicant Name (Manufacturer) :
OXFORD INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002544Device Name
MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM
Manufacturer
OXFORD INSTRUMENTS
Date Cleared
2000-09-13
(27 days)
Product Code
DQK
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
OXFORD INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K984052Device Name
SYNERGY IOM SYSTEM
Manufacturer
OXFORD INSTRUMENTS MEDICAL SYSTEMS
Date Cleared
1999-05-17
(185 days)
Product Code
IKN
Regulation Number
890.1375Why did this record match?
Applicant Name (Manufacturer) :
OXFORD INSTRUMENTS MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Synergy IOM System is a 2, 5, or 10 channel electromyograph which provides facilities for EMG, EEG, Evoked Potentials, ECG and NCV testing to be used for Intra-Operative Monitoring.
Device Description
The Synergy IOM System is a 2, 5, or 10 channel electromyograph.
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K Number
K981405Device Name
SYNERGY LT
Manufacturer
OXFORD INSTRUMENTS, PLC.
Date Cleared
1998-07-16
(87 days)
Product Code
GWF
Regulation Number
882.1870Why did this record match?
Applicant Name (Manufacturer) :
OXFORD INSTRUMENTS, PLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SYNERGY LT is a 2 channel electromyograph which provides facilities for EMG and Evoked Potentials testing for a range of clinical applications.
SYNERGY LT is designed to enable reliable recording, display and documentation of electrophysiological information from the human nervous and muscular system in a clinical environment.
Device Description
The SYNERGY LT is a 2 channel electromyograph which provides facilities for EMG and Evoked Potentials testing for a range of clinical applications.
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K Number
K970902Device Name
MEDILOG FD4
Manufacturer
OXFORD INSTRUMENTS MEDICAL SYSTEMS
Date Cleared
1997-05-05
(55 days)
Product Code
DSH
Regulation Number
870.2800Why did this record match?
Applicant Name (Manufacturer) :
OXFORD INSTRUMENTS MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medilog FD4 Hoher monitor is intended to be used in the diagnosis of various cardiac disorders by the recording of ECG in an ambulatory mode. These disorders principally include cardiac arrhythmia's and myocardial ischeamia.
The ECG data is used by the physician as an aid in the diagnosis of the patients condition. In some circumstances the patient may be hospitalised as part of the medical evaluation and Holter monitoring may be performed in conjunction with other non-invasive or invasive procedures. In such cases there is no interaction between the FD4 and other equipment.
Device Description
Decer poton it looks like an MR63. The difference being the analogue cassette mechanism has been replaced with a digital acquisition module containing a slot for a PCMCIA Flash ATA card.
The patient is connected to the FD4 via disposable electrodes attached to the chest. These detect the electrical signals generated by the heart, which are then transferred to the recorder via the electrode leads and patient cable. In the recorder, these signals are amplified, filtered, digitised and compressed without loss before being stored on a removable PCMCIA Flash ATA card. At the completion of recording the flash memory card is removed and the recorded ECG data is replayed and analysed on the Oxford Instruments ECG Analysis System.
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K Number
K961636Device Name
MEDILOG VISION
Manufacturer
OXFORD INSTRUMENTS, PLC.
Date Cleared
1997-01-17
(263 days)
Product Code
OLZ
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
OXFORD INSTRUMENTS, PLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K961638Device Name
MEDILOG MPA-S
Manufacturer
OXFORD INSTRUMENTS MEDICAL SYSTEMS
Date Cleared
1997-01-17
(263 days)
Product Code
OLV
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
OXFORD INSTRUMENTS MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Recording of a physiological signals (single channel of EEG, and or recording of ECG signals at 64 Hz) that are required to aid in the diagnoses of sleep related disorders.
Device Description
Medilog MPA-S Recorder
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K Number
K961642Device Name
MEDILOG MR95
Manufacturer
OXFORD INSTRUMENTS, PLC.
Date Cleared
1997-01-17
(263 days)
Product Code
GWQ
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
OXFORD INSTRUMENTS, PLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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