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510(k) Data Aggregation

    K Number
    K083066
    Device Name
    CHROMOPHARE E 778 AND E 558
    Manufacturer
    BERCHTOLD HOLDING GMBH
    Date Cleared
    2008-10-30

    (15 days)

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

    BERCHTOLD HOLDING GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CHROMOPHARE® E 778 and E 558 is intended to be used to provide visible illumination to the surgical field of the patient. The surgical lights BERCHTOLD CHROMOPHARE® E 778 and E 558 are intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.
    Device Description
    The new BERCHTOLD CHROMOPHARE® E 778 and E 558 surgical lights are suitable for all types of surgical procedures. With the use of Light Emitting Diodes (LEDs) in these lights, BERCHTOLD realizes high illumination intensity with a lower heat radiation and less pattern variation compared to previous generations of BERCHTOLD products. The light features easy-to-operate swivel arms. Each light functions with an optional integrated CCD video camera and/or with upward "EndoLite" and/or with downward "GuideLite" for endoscopic procedures. The lights could be combined among each other.
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    K Number
    K080857
    Device Name
    CHROMOPHARE E-SERIES
    Manufacturer
    BERCHTOLD HOLDING GMBH
    Date Cleared
    2008-04-10

    (14 days)

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

    BERCHTOLD HOLDING GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CHROMOPHARE® Exxx is intended to be used to provide of the device: visible illumination of the surgical field or the patient. The surgical lights BERCHTOLD CHROMOPHARE® E805, E800, E 655, E 650, E 550 and E 520 are intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.
    Device Description
    The new BERCHTOLD CHROMOPHARE® E805, E800, E655, E650, E550, and E520 (collectively known and referred to in this document as CHROMOPHARE® Exxx) surgical lights are suitable for all types of surgical procedures. With the use of gas-discharging lamps or Halogen bulbs in these lights, BERCHTOLD realizes high illumination intensity with a lower heat radiation and less pattern variation compared to previous generations of BERCHTOLD products. The light features easy-to-operate swivel arms, auto switching to the secondary lamp in case of failure of the primary lamp, and an easy-to-exchange lamp cartridge. Each light functions with an optional integrated CCD video camera and/or with upward "EndoLite" for endoscopic procedures. The lights could be combined among each other.
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    K Number
    K024132
    Device Name
    CHROMOPHARE X 65
    Manufacturer
    BERCHTOLD HOLDING GMBH
    Date Cleared
    2003-03-21

    (95 days)

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

    BERCHTOLD HOLDING GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CHROMOPHARE® X 65 is intended to be used to provide used to provide visible illumination of the surgical field or the patient. The surgical light BERCHTOLD CHROMOPHARE® X65 is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.
    Device Description
    The new BERCHTOLD CHROMOPHARE® X 65 surgical light is suitable for all types of surgical procedures. With the use of gas-discharging lamps in the new light BERCHTOLD realizes a higher illumination intensity with a lower heat radiation. The light incorporates easy-to-operate swivel arms auto switching on the second lamp in case of failure of the main lamp and an easy-to-exchange lamp cartridge. Also an optional CCD-video-camera is available and a special version with "EndoLite" for endoscopical working. The light could be combined with other BERCHTOLD lights.
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    K Number
    K990656
    Device Name
    CHROMOPHARE D 530 LDR SURGICAL LIGHT
    Manufacturer
    BERCHTOLD HOLDING GMBH
    Date Cleared
    1999-07-20

    (141 days)

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

    BERCHTOLD HOLDING GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The surgical light, CHROMOPHARE® D 530 LDR, is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.
    Device Description
    The new Berchtold CHROMOPHARE® D 530 LDR surgical light is suitable for all types of surgical procedures and offers the physician a natural (whiter) and "colder" light. The light quality is based on an optical double filter technique. The CHROMOPHARE® D 530 LDR provides a light intensity of up to 85000 lux. The light has features like a suspension mechanism will allow to move the light head motordriven up and down, auto-switching on the second lamp in case of failure of the main lamp and an easy to exchange lamp cartridge. The new suspension allows the surgeon to move the light out of the treatment area, which is of interest e.g. in labor and delivery rooms. The light has been designed to and meets the requirements of the IEC 601 and UL 544 regulation for safety.
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    K Number
    K991527
    Device Name
    CHROMOPHARE D500, D530, D650
    Manufacturer
    BERCHTOLD HOLDING GMBH
    Date Cleared
    1999-05-27

    (24 days)

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

    BERCHTOLD HOLDING GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surgical lights CHROMOPHARE® D500, D630 and D650, are intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.
    Device Description
    The Berchtold CHROMOPHARE® D Series lights are suitable for all types of surgical procedures and offers the physician a natural (whiter) and "colder" light. The light intensity from 85000lx up to 150000 lux. The light incorporates easy-to-operate switching on the second lamp in case of failure of the main lamp and an easy to exchange lamp cartridge. For the CHROMOPHARE® D650 and D530 is also an optional CCD-video camera available and a special version with "EndoLite" for endoscopical work. The light could be combined with other Berchtold lights and the Hermes OR Control Center from Voice - Sense - See in the EC and Hermes Motion, Inc. The light has been designed to and meets the requirements of the IEC 601 and UL 544 regulation for safety.
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    K Number
    K974433
    Device Name
    CHROMOPHARE D 500, CHROMOPHARE D 530
    Manufacturer
    BERCHTOLD HOLDING GMBH
    Date Cleared
    1998-02-20

    (88 days)

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

    BERCHTOLD HOLDING GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The surgical lights, CHROMOPHARE® D 500 and D 530, are intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.
    Device Description
    The new Berchtold CHROMOPHARE® D 500 and D 530 surgical lights are suitable for all types of surgical procedures and offer the physician a natural (whiter) and "colder" light. The light quality is based on a optical double filter technique. The CHROMOPHARE® D 530 provides a light intensity of up to 110000 lux and the CHROMOPHARE® D 500 up to 85000 lux. The lights have features like easy-to-operate swivel arms, auto-switching on the second lamp in case of failure of the main lamp and an easy to exchange lamp cartridge. For the CHROMOPHARE® D 530 there is also an optional CCD-video camera available and a special version with "EndoLite" for endoscopical procedures. The lights could be combined with other Berchtold lights. The lights have been designed to and meet the requirements of the IEC 601 and UL 2601 regulation for safety.
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    K Number
    K965130
    Device Name
    CHROMOPHARE
    Manufacturer
    BERCHTOLD HOLDING GMBH
    Date Cleared
    1997-07-14

    (203 days)

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

    BERCHTOLD HOLDING GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surgical light. CHROMOPHARE®D-650. is intended to illuminate locally the operating site on the patient's body with a high light intensity. "cold" light.
    Device Description
    Surgical light. CHROMOPHARE®D-650.
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    K Number
    K955750
    Device Name
    TELETOM
    Manufacturer
    BERCHTOLD HOLDING GMBH
    Date Cleared
    1996-02-08

    (52 days)

    Product Code
    FQO
    Regulation Number
    878.4960
    Why did this record match?
    Applicant Name (Manufacturer) :

    BERCHTOLD HOLDING GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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