Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K062952
    Device Name
    C300 SERIES AIR NEBULIZER COMPRESSOR
    Manufacturer
    CHOICE SMART HEALTH CARE CO. LTD.
    Date Cleared
    2007-02-21

    (145 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHOICE SMART HEALTH CARE CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    C300 Series Air Nebulizer Compressor is intended to provide a source of compressed air to a pneumatic nebulizer for the generation of aerosolized medications for inhalation by a patient, based on a physicians' prescription. C300 Series Air Nebulizer Compressor is an AC powered air compressor that provides a source of compressed air for home health care use. The compressor should be used with a pneumatic nebulizer to convert certain inhaled drugs into an aerosol form for inhalation by a patient.
    Device Description
    The C300 Series Air Nebulizer Compressor is AC line powered (120V) device. Only the compressor unit is supplied by the sponsor. Other accessories which are directly contacted the patients are not included in this application. These accessories include Air Tubing, Nebulizer, Adaptor, Flexi Tubing, and Mouthpiece. Suggest selecting those accessories which have already obtained 510(K) clearance and are available on the market. The compressor is driven with a motor inside, and is AC line powered (120V) with an on/off switch. Inside of the compressor also have an inlet filter and a filter cover. Outside is a plastic body (including a top cover, a left cover, and a right cover).
    Ask a Question
    K Number
    K063291
    Device Name
    INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22
    Manufacturer
    CHOICE SMART HEALTH CARE CO. LTD.
    Date Cleared
    2006-11-21

    (20 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHOICE SMART HEALTH CARE CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Infrared Ear Thermometer (IRT-21 and IRT-22), designed with infrared technology, is used to measure body temperature from ear canal. Press the ON/OFF button to turn on the power, insert the probe into the ear canal then press the SCAN button to measure the temperature, when you hear a beep sound, the measurement is complete. Infrared Ear Thermometer (IRT-21 and IRT-22) is intended for household and hospital use on people of all ages.
    Device Description
    Infrared Ear Thermometer (IRT-21 and IRT-22) is used to measure body temperature from ear canal. Operation is based on measuring the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces. Probe cover is used for measuring to ensure accurate temperature measurement. For hygienic purpose, it is advised to discard the probe cover after each use. Press the ON/OFF button to turn on the power, the symbol 1888 appears immediately. Insert the probe into the ear canal then press the SCAN button to measure the temperature, when you hear a beep sound, the measurement is complete. The temperature is graduated on 0.1 Tor 0.1 ℃, reading a range of 89.6°F -- 109.2°F (32°C -- 42.9°C ). The ambient temperature environment is intended for used is 50°F -- 104°F (10°C-40°C).
    Ask a Question
    K Number
    K062016
    Device Name
    RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES
    Manufacturer
    CHOICE SMART HEALTH CARE CO. LTD.
    Date Cleared
    2006-10-27

    (102 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHOICE SMART HEALTH CARE CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is an electronic thermometer used for clinical temperature measurement. It is intended for use at home and hospital environment for both children and adult.
    Device Description
    The Rapid Digital Thermometer is an electronic thermometer by using a thermistor as the temperature sensor. The thermometer uses a 1.5V button battery for operation.
    Ask a Question

    Page 1 of 1