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510(k) Data Aggregation

    K Number
    K050027
    Device Name
    LAPAROCISION SCOPE CONTROLLER SYSTEM
    Manufacturer
    GMP/COMPANIES, INC.
    Date Cleared
    2005-01-27

    (21 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    GMP/COMPANIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GMP|Surgical Solutions Inc. Laparocision™ Scope Controller System is indicated for thoracic, gynecologic, orthopedic, and abdominal procedures for the purpose of holding and controlling the movement of standard laparoscopes or rigid endoscopes within inflated surgical cavities during minimally invasive laparoscopic surgery.
    Device Description
    The GMP|Surgical Solutions Laparocision™ Scope Controller System allows for surgeons to control the movement and position of conventional laparoscopes or endoscopes during thoracic, gynecologic, orthopedic, and abdominal laparoscopic procedures by means of an electromechanical arm which is controlled by either a hand controller or a foot controller. The purpose of an endoscope is to allow visualization of a surgical cavity during minimally invasive laparoscopic procedures. The device is comprised of the following five main components: 1) The Laparocision™ Reusable Arm Assembly 2) The Disposable Zoom Assembly (DZA) 3) The Foot Control and the Hand Control 4) The Steri-Sleeves 5) The Power Supply
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    K Number
    K030795
    Device Name
    LIFESYNE SYSTEMS
    Manufacturer
    GMP/COMPANIES, INC.
    Date Cleared
    2003-08-05

    (146 days)

    Product Code
    DRG
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    GMP/COMPANIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GMP|Wireless Medicine LifeSync™ System is indicated for use when ECG monitoring is needed and a wireless cable-free connection is desired between the patient and the ECG Monitor. The LifeSync™ System will also transmit the patient respiration waveform for those ECG systems that include a respiration function. The GMP/Wireless Medicine LifeSync™ System is intended for use as a radiofrequency signal transmitter and receiver of diagnostic electrocardiographic physiological signals which are displayed on the ECG monitors of various manufacturers' systems that have been validated for compatibility. ECG systems that are not currently wireless in operation will now be able to be used in a wireless fashion by virtue of being connected to the GMP system. The LifeSync™ System will also transmit the patient respiration waveform for those ECG systems that include a respiration function. The GMPIWireless Medicine LifeSync™ System will eliminate the wires between the ECG patient and the ECG monitor and will replace the traditional ECG cable with a radio link. The GMP|Wireless Medicine LifeSync™ System will support the standard 5-lead ECG hook-up (via the Continuous Leadwear™) for monitoring and has the capability to add the remaining V1-V6 precordial leads (via the Discrete Leadwear™) for 12-lead discrete ECG recording.
    Device Description
    The GMP|Wireless Medicine LifeSync™ System is comprised of 4 primary components and 1 accessory component: 1) a patient wearable 5-electrode array called the Continuous Leadwear™, 2) a patient wearable 6-electrode array called the Discrete Leadwear™, 3) LifeSync™ Patient Transceiver-with Armband , and 4) a LifeSync™ Monitor Transceiver. The accessory component is: 5) an optional Multi-Unit Battery Charger. The LifeSync™ Patient Transceiver will be responsible for sampling ECG waveforms from the electrode array and converting these signals into digital data. It will then transmit this data over a wireless Bluetooth link to the Monitor Transceiver. The LifeSync™ Monitor Transceiver will reconstruct the analog signals from the received digital data and present these signals to the normal inputs of a standard Continuous Cardiac Monitor or Discrete Diagnostic ECG System. The LifeSync™ System has been validated for use with several ECG systems of various manufacturers.
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