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510(k) Data Aggregation

    K Number
    K170423
    Device Name
    DentureID Microchip
    Manufacturer
    CMP Industries LLC
    Date Cleared
    2017-10-25

    (254 days)

    Product Code
    PYQ, LWH, NRV, OUG
    Regulation Number
    880.6300
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DentureID Microchip is intended to enable access to secure patient identification and device information when used with complete dentures, partial dentures and other removable oral appliances.
    Device Description
    DentureID Microchip enables access to secure patent identification and device information when used with removable oral appliances. The microchip is permanently embedded into a denture and is a digital link to owner contact information and information about the denture in the event that a repair or replacement is needed. All of the information is controlled on the secure DentureID.com website by the denture owner and dental professional. The DentureID Microchip can be read by any NFC compatible Android Smart Phone (after downloading the DentureID.com App from Google Play) and holding the phone against the microchip. The information on the DentureID.com website may be modified at any time by the patient or dental professional by entering a username and password. The information that is on the website will appear on the smart phone when reading the DentureID Microchip. DentureID Microchips are classified as RFID ISO 14443 which use NFC (near-field-communication). DentureID Microchips are designed to be read by ISO 14443 NFC-compliant smart phones with DentureID App installed. DentureID Microchips are encased in a medical-grade epoxy resin. The size is 1.5mm X 6 mm in diameter. They are inserted into the buccal flange of a denture and completely covered with self-cure repair resin. The DentureID Microchip does not directly contact the patient.
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    K Number
    K983049
    Device Name
    AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER
    Manufacturer
    AMERICAN ELECTROMEDICS CORP.
    Date Cleared
    1998-11-18

    (78 days)

    Product Code
    ETY
    Regulation Number
    874.1090
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The American Electromedics Quik Tymp 1 (QT1) Tympanometer With Integral Printer is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.
    Device Description
    The American Electromedics Quik Tymp 1 (QT1) Tympanometer/Audiometer With Integral Printer is an impedance tympanometer. The American Electromedics Quik Tymp 1 (QT1) Tympanometer with Integral Printer is an impedance tympanometer which has a built-in printer.
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    K Number
    K983051
    Device Name
    AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
    Manufacturer
    AMERICAN ELECTROMEDICS CORP.
    Date Cleared
    1998-11-18

    (78 days)

    Product Code
    ETY
    Regulation Number
    874.1090
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    Matched: '880.6300'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The American Electromedics Race Car Tympanometer/ Audiometer With Integral Printer is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.
    Device Description
    The American Electromedics Race Car Tympanometer/Audiometer With Integral Printer is a combination device which can be used as a tympanometer or as an audiometer, and has a built-in printer.
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    K Number
    K983046
    Device Name
    AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER
    Manufacturer
    AMERICAN ELECTROMEDICS CORP.
    Date Cleared
    1998-11-17

    (77 days)

    Product Code
    ETY
    Regulation Number
    874.1090
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    Matched: '880.6300'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The American Electromedics Race Car Tympanometer With Integral Printer is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.
    Device Description
    The American Electromedics Race Car Tympanometer With Integral Printer is an impedance tympanometer.
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    K Number
    K983048
    Device Name
    AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
    Manufacturer
    AMERICAN ELECTROMEDICS CORP.
    Date Cleared
    1998-11-17

    (77 days)

    Product Code
    EWO
    Regulation Number
    874.1050
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The American Electromedics Quik Tymp 2 (QT2) Tympanometer/Audiometer With Integral Printer is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.
    Device Description
    The American Electromedics Quik Tymp 2 (QT2) Tympanometer/Audiometer With Integral Printer is a combination device which can be used as a tympanometer or as an audiometer, and has a built-in printer.
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    K Number
    K960044
    Device Name
    ULTRAMAX/MODEL NUMBER A1
    Manufacturer
    ENTLAB OY
    Date Cleared
    1996-08-02

    (213 days)

    Product Code
    LWI
    Regulation Number
    892.1560
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ultramax ultrasonic diagnostic system is intended to assist the physician in the diagnosis of maxillary and frontal sinusitis by detecting fluid in the sinus cavity.
    Device Description
    The Ultramax is an A-scan, pulseecho device, equipped with a single unfocused flat 8 mm 3 MHz transducer. Pulse repetition rate is fixed at 300 Hz. The only controls on the device are the receiver gain, and the range that can be selected between "8" (0-8 cm), " 4 " (0-4 cm) and "4E" (4-8 cm). These selections do not effect the emitted acoustic power.
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