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510(k) Data Aggregation

    K Number
    K142486
    Device Name
    HEINE BETA 200, HEINE BETA 200 S, HEINE K 180
    Manufacturer
    HEINE Optotechnik GmbH & Co. KG
    Date Cleared
    2015-05-18

    (256 days)

    Product Code
    HLJ
    Regulation Number
    886.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    **HEINE Optotechnik GmbH **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HEINE Direct ophthalmoscopes are intended for examination of the media (cornea, aqueous humour, lens, vireous humour) and retina of the eye.
    Device Description
    HEINE BETA® 200, HEINE BETA® 200S and HEINE K180® Ophthalmoscopes are battery powered hand-held devices to that provide illumination, viewing optics, apertures and filters in order to examine the media and the retina of a patient's eye. Each device consists of an instrument head with bulb and a battery handle that can be attached to the instrument head. The devices are differentiated by the various number and type of apertures and filters and by the different range and number of corrective lenses.
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    K Number
    K142837
    Device Name
    HEINE SIGMA 250 & HEINE SIGMA 250 M2
    Manufacturer
    HEINE Optotechnik GmbH & Co. KG
    Date Cleared
    2015-01-29

    (121 days)

    Product Code
    HLJ
    Regulation Number
    886.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    **HEINE Optotechnik GmbH **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HEINE SIGMA® 250 (M2) are battery powered indirect ophthalmoscopes for medical professionals, containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye.
    Device Description
    The HEINE SIGMA® 250 (M2) are indirect ophthalmoscopes, worn on the user's head to provide illumination and viewing optics in order to examine the media and the retina of a patient`s eye. The indirect ophthalmoscopes are battery operated.
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    K Number
    K131959
    Device Name
    HEINE MINI 3000(R) OPHTHALMOSCOPE
    Manufacturer
    HEINE OPTOTECHNIK GMBH & CO. KG.
    Date Cleared
    2014-03-07

    (253 days)

    Product Code
    HLJ, DEV
    Regulation Number
    886.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    **HEINE OPTOTECHNIK GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HEINE mini 3000 Ophthalmoscope is a battery powered hand-held device for medical professionals, containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye.
    Device Description
    The HEINE mini 3000® Ophthalmoscope is a battery powered hand-held device to provide illumination and viewing optics in order to examine the media and the retina of a patient's eye. It consists of an instrument head and a battery handle that can be screwed onto the instrument head. The ophthalmoscope can be either operated by replaceable AA batteries or a rechargeable option in combination with the HEINE mini NT® charger.
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    K Number
    K131961
    Device Name
    HEINE BETA 200(R) OPHTHALMOSCOPE
    Manufacturer
    HEINE OPTOTECHNIK GMBH & CO. KG.
    Date Cleared
    2013-12-04

    (160 days)

    Product Code
    HLJ, HIL
    Regulation Number
    886.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    **HEINE OPTOTECHNIK GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This instrument is designed for examination of the eye. BETA handles are designed exclusively for use with medical examination instruments with bulb illumination.
    Device Description
    The HEINE BETA 200® Ophthalmoscope is a battery powered hand-held device to provide illumination and viewing optics in order to examine the retina of a patient's eye. It consists of an instrument head and a battery handle that can be attached to the instrument head.
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    K Number
    K123587
    Device Name
    HEINE MINI 3000 LED OPHTHALMOSCOPE
    Manufacturer
    HEINE OPTOTECHNIK GMBH & CO. KG.
    Date Cleared
    2013-03-22

    (121 days)

    Product Code
    HLJ
    Regulation Number
    886.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    **HEINE OPTOTECHNIK GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HEINE mini 3000® LED Ophthalmoscope is a battery powered hand-held device for medical professionals, containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye.
    Device Description
    The HEINE mini 3000® LED Ophthalmoscope is a battery powered hand-held device to provide illumination and viewing optics in order to examine the retina of a patient's eve. It consists of an instrument head and a battery handle that can be screwed onto the instrument head. The ophthalmoscope can be either operated by replaceable AA batteries or a rechargeable option in combination with the HEINE mini NT® charger.
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    K Number
    K123316
    Device Name
    HEINE OMEGA 500
    Manufacturer
    HEINE OPTOTECHNIK GMBH & CO. KG.
    Date Cleared
    2013-02-26

    (124 days)

    Product Code
    HLI, DEV, HLJ
    Regulation Number
    886.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    **HEINE OPTOTECHNIK GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indirect ophthalmoscope HEINE OMEGA® 500 is an AC-powered or battery powered device for medical professionals, containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye.
    Device Description
    The HEINE OMEGA® 500 is an indirect ophthalmoscope, worn on the user's head to provide illumination and viewing optics in order to examine the retina of a patient's eve. The ophthalmoscope can be operated either by rechargeable battery or directly by mains power supply. The HEINE OMEGA® 500 allows wireless comfortable movement for the user and mobile charging (depending on chosen power source).
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    K Number
    K101892
    Device Name
    HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M-
    Manufacturer
    HEINE OPTOTECHNIK GMBH & CO. KG.
    Date Cleared
    2010-08-27

    (51 days)

    Product Code
    DXQ
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    **HEINE OPTOTECHNIK GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HEINE GAMMA aneroid sphygmomanometers are exclusively designed for measuring blood pressure at the upper arm or thigh on healthy skin.
    Device Description
    The HEINE Gamma aneroid sphygmomanometers are non-invasive blood-pressure measurement devices to measure systolic and diastolic blood pressure in adults and pediatric patients. The HEINE Gamma sphygmomanometers consist of a large insufflation bulb, a gauge with a large diameter scale, a valve, and a single tube cuff with Velcro fastener. The HEINE Gamma sphygmomanometers come in five models; G5, G7, GP, GST, and XXL LF. The models comprise either a push-button valve or a spin valve. The HEINE Gamma GST comprises an integrated stethoscope for self measurement. The HEINE Gamma XXL LF is a wall-, desk-, or rail-mounted devices and is available with a wheeled stand. HEINE Gamma G5, G7, GP, and XXL LF will be available in five cuff sizes; child small, child, adult small, adult, and thigh. The HEINE Gamma GST comes with an adult cuff. The HEINE Gamma aneroid sphygmomanometers are intended for use in a wide variety of settings. This includes hospital departments, medical practices, and nursing homes, as well as home health care.
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