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510(k) Data Aggregation

    K Number
    K182950
    Device Name
    Acare Suction Unit
    Manufacturer
    Acare Technology Co., Ltd.
    Date Cleared
    2019-08-23

    (304 days)

    Product Code
    JCX
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    Acare Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is to be used to remove fluids from the airway or respiratory system. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection canister. The fluids are trapped in the collection canister for proper disposal. It is for use on the order of a physician only.
    Device Description
    The Acare Suction Unit, model ASU-200 is to be used to remove fluids from the airway or respiratory system. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection canister. The fluids are trapped in the collection canister for proper disposal. The device is a rugged, compact and portable electrically-operated medical suction device, designed for multi-source powering from AC (External 100V- 240 V) or DC (External 12V DC) mains supply or internal rechargeable battery, and is ideally suited for field, transport and hospital/clinical use applications. The Acare canister is an accessory to the Acare Pump and the removed body fluids are collected in it. The Acare Pump is an AC powered oil-less positive displacement pump capable of delivering up to 600 mmHg of vacuum to draw fluid and small particles. The Acare Pump has a plastic casing fitted with a power (ON/OFF) button, power indicator, one suction adjustment knob, a suction gauge and a canister holder. The Acare canister is a preassembled 1000 mL canister including canister tubing fitted with a microbial filter at the distal end. The canister is fitted with a removable lid for fluid containment and an overflow protection device. The Acare canister should be placed in the in-built canister holder and connect the Acare canister with the Acare Pump via the connectors of the canister tubing prior to use.
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    K Number
    K111617
    Device Name
    PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1
    Manufacturer
    ACARE TECHNOLOGY CO., LTD.
    Date Cleared
    2011-12-22

    (195 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACARE TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Finger Type Pulse Oximeter, AB-F1 is indicated for spot checking of functional arterial oxygen saturation (SpO2) and pulse rate in hospital type facilities as well as in the home care environment. It is intended for adult patients use. Handheld Pulse Oximeter, AH-S1 is indicated for spot checking of functional arterial oxygen saturation (SpO2) and pulse rate in hospital type facilities as well as in the home care environment. It is intended for adult, pediatric and neonatal patients use. Handheld Pulse Oximeter, AH-M1 is indicated for spot checking of functional arterial oxygen saturation (SpO2) and pulse rate in hospital type facilities as well as in the home care environment. It is intended for adult, pediatric and neonatal patients use.
    Device Description
    Not Found
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