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510(k) Data Aggregation

    K Number
    K101537
    Device Name
    AIM 200, MAJOR SURGICAL LIGHT
    Manufacturer
    BURTON MEDICAL PRODUCTS CORP.
    Date Cleared
    2010-09-30

    (119 days)

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

    BURTON MEDICAL PRODUCTS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AIM 200® OR Major Surgical Light is designed to provide the required illumination for surgeries, procedures, and examinations of patients. The AIM 2000 OR Major Surgical Light is to be used with various mounting configurations in operating rooms, examination rooms, emergency rooms and all other health care facilities where the need for additional illumination exists.
    Device Description
    The new AIM 200® OR is intended to be used in Acute care arena in operating theaters, emergency rooms, trauma centers, and endo-suites as well as in ASC's for endo-suites, plastic surgery, ophthalmology and orthopedic procedures. It is available in floor, wall, single ceiling and double ceiling models. The new AIM 200® OR combines the smart and versatile styling of the existing AIM 50® and AIM 100® with the increased luminance of a Major OR product. The AIM 200® OR uses proven AIM 100® optical modules at increased powers to yield illuminance of 90,000 Lux at 1 meter while meeting the D50/D10 light distribution ratio required by the IEC 60601-2-41 standard for Major Surgical Lighting.
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    K Number
    K042395
    Device Name
    OUTPATIENT III MINOR SURGERY LIGHT
    Manufacturer
    BURTON MEDICAL PRODUCTS CORP.
    Date Cleared
    2004-12-01

    (90 days)

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

    BURTON MEDICAL PRODUCTS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Outpatient® III Minor Surgery Light is designed to provide the required illumination for examinations of patients. The Outpatient® III light is to be used with various mounting configurations in operating rooms, examination rooms, and other health care facilities where the need for additional illumination exists.
    Device Description
    Not Found
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    K Number
    K000639
    Device Name
    VISIONARY 2000
    Manufacturer
    BURTON MEDICAL PRODUCTS CORP.
    Date Cleared
    2000-05-25

    (90 days)

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

    BURTON MEDICAL PRODUCTS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K963682
    Device Name
    GENIE' SINGLE CEILING AND DOUBLE CEILING
    Manufacturer
    BURTON MEDICAL PRODUCTS CORP.
    Date Cleared
    1996-11-13

    (71 days)

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

    BURTON MEDICAL PRODUCTS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961843
    Device Name
    GENIE
    Manufacturer
    BURTON MEDICAL PRODUCTS CORP.
    Date Cleared
    1996-08-22

    (101 days)

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

    BURTON MEDICAL PRODUCTS CORP.

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