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510(k) Data Aggregation

    K Number
    K162589
    Device Name
    Adscope 658 Electronic Stethoscope
    Manufacturer
    AMERICAN DIAGNOSTIC CORP.
    Date Cleared
    2017-03-10

    (175 days)

    Product Code
    DQD
    Regulation Number
    870.1875
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN DIAGNOSTIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Adscope® 658 Electronic Stethoscope is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung, and other body sounds. Frequency selection and volume buttons enable operator control. The 658 can be used on patients of any age undergoing a physical assessment. This device is designed for use in a professional setting by a healthcare practitioner.
    Device Description
    The Adscope® 658 Electronic Stethoscope is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung, and other body sounds. Frequency selection and volume buttons enable operator control.
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    K Number
    K093495
    Device Name
    OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS
    Manufacturer
    AMERICAN DIAGNOSTIC CORP.
    Date Cleared
    2010-11-19

    (374 days)

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

    AMERICAN DIAGNOSTIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ophthalmoscope is a hand held, battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye. It is intended to be used by a trained healthcare professional.
    Device Description
    The ophthalmoscope kits described in this submission include a battery handle and attachments which serve the intended use below. The ophthalmoscope is a hand held, battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.
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    K Number
    K060321
    Device Name
    ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK
    Manufacturer
    AMERICAN DIAGNOSTIC CORP.
    Date Cleared
    2006-05-15

    (95 days)

    Product Code
    DQD
    Regulation Number
    870.1875
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN DIAGNOSTIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ADSCOPE 657BK Electronic Stethoscope is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung, and other body sounds with the use of selective frequency and can be used on any patient undergoing a physical assessment.
    Device Description
    Not Found
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    K Number
    K012304
    Device Name
    ADC 656 ELECTRONIC STETHOSCOPE
    Manufacturer
    AMERICAN DIAGNOSTIC CORP.
    Date Cleared
    2001-11-01

    (104 days)

    Product Code
    DQD
    Regulation Number
    870.1875
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN DIAGNOSTIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For listening and amplification of sounds associated with the heart, arteries, veins and other internal organs, using the principles of electronic amplification to intensify the acoustical sounds of the device. American Diagnostic Corporation's number 656 Electronic Stethoscope indications for use as an electronic stethoscope which will electronically amplfy sounds associated with the heart, arteries, veins and other internal organs. American Diagnostic intends to provide this device for use by healthcare providers and not for use by the general public.
    Device Description
    ADC #656BK Electronic Scope Basic design is identical in both operation and functionality to the Graham-Field Healthcare Products, Labtron Electronmax (510(k) K961857). The main amplifying chestpiece is identical to the Graham-Field Healthcare Products stethoscope in design, function and performance. The headset assembly is identical to one used on numerous other ADC stethoscopes (510(k) 935544).
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    K Number
    K962655
    Device Name
    ANEROID AND MERCURIAL SPHYGMOMANOMETERS
    Manufacturer
    AMERICAN DIAGNOSTIC CORP.
    Date Cleared
    1997-01-27

    (203 days)

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

    AMERICAN DIAGNOSTIC CORP.

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