Search Filters

Search Results

Found 7 results

510(k) Data Aggregation

    K Number
    K991819
    Device Name
    MAGNATEK 30
    Manufacturer
    MAGNA ADVANCED TECHNOLOGIES, INC.
    Date Cleared
    1999-08-19

    (84 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAGNA ADVANCED TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K982907
    Device Name
    MAGNATEK 40
    Manufacturer
    MAGNA ADVANCED TECHNOLOGIES, INC.
    Date Cleared
    1998-10-02

    (45 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAGNA ADVANCED TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MTEK-40 hand held pulse oximeter is used to measure the percent arterial oxygen saturation by using a completely non-invasive finger sensor. The oxygen saturation sensor contains LEDs which emit two specific wavelengths of light through a pulsating vascular bed. The MTEK-40 can also measure pulse rate and pulse strength. Continuous arterial oxygen saturation monitoring is valuable in any situation where oxygen administration is indicated. Real time information allows for earlier detection of hypoxia or hyperoxia tan arterial sampling. Federal Law restricts the use of this device by or on the order of a qualified physician only.
    Device Description
    Hand Held Pulse Oximeter, Device Model: MTEK-40. The oxygen saturation sensor contains LEDs which emit two specific wavelengths of light through a pulsating vascular bed.
    Ask a Question
    K Number
    K983114
    Device Name
    MAGNATEK80
    Manufacturer
    MAGNA ADVANCED TECHNOLOGIES, INC.
    Date Cleared
    1998-09-22

    (18 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAGNA ADVANCED TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MagnaTek 80 hand held CO2 Monitor (Capnometer) is intended to be used as a transportable capnometer, providing End-Tidal CO2, respiration rate, and real-time breath indications for use in clinical settings including patient transport, ICU, CCU, ER, OR, and recovery room. The Capnometer can be used for patient checking (spot checking) and data logging of End Tidal CO2 and respiration rate.
    Device Description
    Hand Held CO2 Monitor (Capnometer) Model: MTEK-80
    Ask a Question
    K Number
    K982846
    Device Name
    MTEK-1400
    Manufacturer
    MAGNA ADVANCED TECHNOLOGIES, INC.
    Date Cleared
    1998-09-18

    (37 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAGNA ADVANCED TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MTEK-1400 unit is to be used to in order to measure CO2 concentration using the principles of infrared absorption spectrometry. This unit provides continuous non-invasive information used to aid the clinician in assessing a patient's cardiopulmonary function and metabolic state. It is extremely effective in determining the efficacy of various respiratory treatments. Capnography can aid in detecting esophageal intubations, disconnections, apnea, malignant hyperthermia and air emboli. The MTEK-1400 can also measure respiration rate and capnography. The MTEX-1400 Plus model is capable of measuring percent arterial oxygen saturation and pulse rate.
    Device Description
    Not Found
    Ask a Question
    K Number
    K982405
    Device Name
    MTEK-1000
    Manufacturer
    MAGNA ADVANCED TECHNOLOGIES, INC.
    Date Cleared
    1998-09-17

    (69 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAGNA ADVANCED TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MTEK-1000 unit is to be used to measure percent of arterial oxygen saturation and pulse rate by using a completely non-invasive sensor. The oxygen saturation sensor contains LEDs which emit two specific wavelengths of light through a pulsating vascular bed. The MTEK-1000-US oximeters are equipped to monitor ECG waveforms and can be used to measure cardiac activity.
    Device Description
    The MTEK-1000 unit is a pulse oximeter. The oxygen saturation sensor contains LEDs which emit two specific wavelengths of light through a pulsating vascular bed. The MTEK-1000-US oximeters are equipped to monitor ECG waveforms.
    Ask a Question
    K Number
    K981310
    Device Name
    MAGNATEK C-300
    Manufacturer
    MAGNA ADVANCED TECHNOLOGIES, INC.
    Date Cleared
    1998-07-09

    (90 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAGNA ADVANCED TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    C-300 Coagulator is used in small surgical procedures in The dermatology, plastic surgery and general surgery in order to only coagulate (burn) an open wound or skin lesions. This device does not cut the skin, it only closes open wounds or lesions by coagulating (burning) the skin in any of the small surgical procedures mentioned above.
    Device Description
    Coagulator Device Name: C-300
    Ask a Question
    K Number
    K981416
    Device Name
    MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15
    Manufacturer
    MAGNA ADVANCED TECHNOLOGIES, INC.
    Date Cleared
    1998-06-24

    (65 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAGNA ADVANCED TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ESU-10 / ESU-15 units is to be used in order to cut and coagulate (burn) the skin in surgical procedures.
    Device Description
    Electrosurgical Units, Device Model: ESU-10 / ESU-15
    Ask a Question

    Page 1 of 1