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510(k) Data Aggregation

    K Number
    K992607
    Device Name
    SONICAID SYSTEM 8002
    Manufacturer
    OXFORD INSTRUMENTS MEDICAL SYSTEMS
    Date Cleared
    2001-04-27

    (633 days)

    Product Code
    HGM
    Regulation Number
    884.2740
    Why 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
    K984052
    Device Name
    SYNERGY IOM SYSTEM
    Manufacturer
    OXFORD INSTRUMENTS MEDICAL SYSTEMS
    Date Cleared
    1999-05-17

    (185 days)

    Product Code
    IKN
    Regulation Number
    890.1375
    Why 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
    K970902
    Device Name
    MEDILOG FD4
    Manufacturer
    OXFORD INSTRUMENTS MEDICAL SYSTEMS
    Date Cleared
    1997-05-05

    (55 days)

    Product Code
    DSH
    Regulation Number
    870.2800
    Why 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
    K961638
    Device Name
    MEDILOG MPA-S
    Manufacturer
    OXFORD INSTRUMENTS MEDICAL SYSTEMS
    Date Cleared
    1997-01-17

    (263 days)

    Product Code
    OLV
    Regulation Number
    882.1400
    Why 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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