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510(k) Data Aggregation

    K Number
    K140460
    Device Name
    MACH LED 2SC
    Manufacturer
    DR. MACH GMBH & CO. KG
    Date Cleared
    2014-04-03

    (38 days)

    Product Code
    FSY
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    **DR. MACH GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The surgical light Mach LED 2SC is intended to illuminate the surgical field and the patient.
    Device Description
    The surgical light Mach LED 2SC is intended to illuminate the surgical field and the patient. The Mach LED 2SC consists of lamp housing, LED modules, optical -/electrical and mechanical components, one sterilizable handle sleeve as well as the cables. One LED-module consists of one white LED. The light system can be added to the ceiling mounted suspension system supporting the horizontal arms and spring arms. The horizontal arms can be rotated horizontally with 360°, the spring arms can be rotated horizontally with 360° and moved vertically with 50° downwards and 45° upwards. The light system is operated by a kevpad on the lamp head or, by special request of the customer, by a keypad on the wall. The surgical light Mach LED 2SC will be marketed with merging of light fields and light intensity control. Color temperature adjustment will not be available. Available accessories for the Mach LED 2SC lighting systems are as follows: - Camera module . - Remote control of camera module . - Remote control with network interface for camera module . - Single monitor yoke for flat panel monitors . - Double monitor yoke for flat panel monitors . - Instrument trays . - Trays for CRT monitors - 24V DC battery backup support . - . Low profile wall control unit - Integrated laser pointer . - Sterilizable handle sleeves
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    K Number
    K140461
    Device Name
    MACH LED 2MC
    Manufacturer
    DR. MACH GMBH & CO. KG
    Date Cleared
    2014-04-03

    (38 days)

    Product Code
    FSY
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    **DR. MACH GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The surgical light Mach LED 2MC is intended to illuminate the on the patient's body with a high intensity, shadow-free and "cold" light. The Mach LED 2MC lighting system is designed for illuminating an examination area and surgical field at the hospital and doctor's practice.
    Device Description
    The surgical light Mach LED 2MC is intended to illuminate the operation site on the patient's body with a high intensity, shadow free and "cold" light. The Mach LED 2MC consists of lamp housing, LED modules, optical, electrical and mechanical components, one sterilizable handle sleeve as well as the cables. One LED-module consists of 4 different-colored LEDs: warm white, cold white, green and red. The four different colors are merged inside the lamp head by a computercalculated optical system with light guide and facetted lenses. The light system can be added to the ceiling mounted suspension system supporting the horizontal arms and spring arms. The horizontal arms can be rotated horizontally with 360°, the spring arms can be rotated horizontally with 360° and moved vertically with 50° downwards and 45° upwards. The light system is operated by a keypad on the lamp head or, by special request of the customer, by a keypad on the wall. The surgical light Mach LED 2MC will be marketed with merging of light fields, light intensity control, color temperature adjustment and integrated laser pointer.
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    K Number
    K093009
    Device Name
    MACH LED SC
    Manufacturer
    DR. MACH GMBH & CO. KG
    Date Cleared
    2010-04-01

    (184 days)

    Product Code
    FSY
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    **DR. MACH GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mach LED SC lighting system is designed for illuminating an examination area and surgical field at the hospital and doctor's practice. The surgical light Mach LED SC is intended to illuminate the surgical field and the patient.
    Device Description
    The surgical light Mach LED SC is intended to illuminate the surgical field and the patient. This light system can be added to the ceiling mounted suspension system supporting the horizontal arms and spring arms. The horizontal arms can be rotated horizontally with 360°, the spring arms can be rotated horizontally with 360° and moved vertically with 50° downwards and 45° upwards. The light system is operated by a keypad on the lamp head or, by special request of the customer, by a keypad on the wall. The Mach LED SC consists of lamp housing, LED modules, optical -/electrical and mechanical components, one sterilizable handle sleeve as well as the cables. One LED-module consists of one white LED. The surgical light Mach LED SC will be market with merging of light fields and light intensity control. Colour temperature adjustment not available. Available accessories for the Mach LED SC lighting systems are as follows: - Camera module - Remote control for camera module - Remote control with network interface for camera module - Single monitor yoke for flat panel monitors - Double monitor yoke for flat panel monitors - Instrument trays - Trays for CRT monitors - 24V DC battery backup support - Low profile wall control unit - Integrated laser pointer - Sterilizable handle sleeves
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    K Number
    K093010
    Device Name
    MACH LED MC
    Manufacturer
    DR. MACH GMBH & CO. KG
    Date Cleared
    2010-04-01

    (184 days)

    Product Code
    FSY
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    **DR. MACH GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mach LED MC lighting system is designed for illuminating an examination area and surgical field at the hospital and doctor's practice. The surgical light Mach LED MC is intended to illuminate the operating site on the patient's body with a high intensity, shadow-free and "cold" light.
    Device Description
    The surgical light Mach LED MC is intended to illuminate the operating site on the patient's body with a high intensity, shadow-free and "cold" light. This light system can be added to the ceiling mounted suspension system supporting the horizontal arms and spring arms. The horizontal arms can be rotated horizontally with 360°, the spring arms can be rotated horizontally with 360° and moved vertically with 50° downwards and 45° upwards. The light system is operated by a keypad on the lamp head or, by special request of the customer, by a keypad on the wall. The Mach LED MC consists of lamp housing, LED modules, optical -/electrical and mechanical components, one sterilizable handle sleeve as well as the cables. One LED-module consists of 4 different-coloured LED's: warm white, cold white, green and red. The four different colours are merged inside the lamphead by a computer-calculated optical system with light quide and facetted lenses. The surgical light Mach LED MC will be market with merging of light intensity control, colour temperature adjustment and integrated laser pointer. Available accessories for the Mach LED MC lighting systems are as follows: - Camera module - Remote control for camera module - Remote control with network interface for camera module - Single monitor yoke for flat panel monitors - Double monitor yoke for flat panel monitors - Instrument trays - Trays for CRT monitors - 24V DC battery backup support - Low profile wall control unit - Sterilizable handle sleeves
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