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510(k) Data Aggregation

    K Number
    K181398
    Device Name
    DV-300 Aspirator
    Manufacturer
    Ding Hwa Co., Ltd.
    Date Cleared
    2018-07-23

    (55 days)

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

    Ding Hwa Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DV-300 is intended for general suction use in hospitals or clinics.
    Device Description
    The DV-300 is a portable AC suction pump capable of delivering 24.4 inHg of negative pressure (vacuum) to draw fluids and small particles through tubing and into a disposable collection canister, where the suctioned fluids and particles are trapped for proper disposal. The device is comprised of a maintenance-free pump unit, a power cord, an on/off switch, a pressure relief valve and pressure adjustment knob, an analog pressure gauge, a microbial filter, intermediate tubing, and a disposable collection canister (≥ 800 ml) with overflow protection. The DV-300 requires an AC input voltage of 110-120V 60Hz. Housed in ABS plastic, the DV-300 has an IP22 ingress protection rating; and, as a Class II (double-insulated) electrical appliance, the unit affords Type BF applied part protection against electric shock. The DV-300 must only be used on the order of a physician.
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    K Number
    K140809
    Device Name
    CLIQ DV-300 ASPIRATOR
    Manufacturer
    DING HWA CO., LTD.
    Date Cleared
    2014-06-23

    (83 days)

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

    DING HWA CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to be used for aspiration during flexible endoscopy.
    Device Description
    The Cliq Aspirator model DV-300 is an AC-powered high-vacuum / low-flow suction unit used for endoscopic aspiration. The DV-300 creates a negative pressure (vacuum) that draws fluids through disposable tubing, and into a collection container. The fluids are trapped within the collection container for proper disposal. The device is comprised of a maintenance-free pump unit; power cord, on/off switch, pressure relief valve, pressure adjustment knob, pressure gauge, microbial filter, and intermediate tubing. The Cliq Aspirator: model DV-300 requires 110-120 V and 60 Hz. It has Class II with Type BF applied part protection against electric shock. The DV-300 suction pump operates via a piston pump type, and has a maximum vacuum pressure of 620 mm Hg. The pump produces a flow rate of up to 18 Liters per minute.
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    K Number
    K132308
    Device Name
    CLIQ DV-300 ASPIRATOR
    Manufacturer
    DING HWA CO., LTD.
    Date Cleared
    2013-12-30

    (158 days)

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

    DING HWA CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is to be used to remove fluids from the treated tracheotomy patient airway.
    Device Description
    The predicate devices and the subject device have the same technological characteristics. Those devices are intended to be used to remove fluids from the treated tracheotomy patient airway. It creates a negative pressure (vacuum) that draws the fluids through disposable tubing that is connected to a collection jar. The fluids are trapped in the collection jar for the proper disposal. The devices are for use on the order of a physician only. If practiced out of the hospital, the care giver has to be trained and recorded. The predicate devices and the subject device are the portable AC powered suction pumps. Each one consists of an on/off switch, a pump unit, a non-detachable flexible power cord, collection jar, relief valve, pressure gauge, pressure adjustment knob, bacteria filter, suction tubing. The major differences between the predicate devices and the subject device are the capacities and dimensions.
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    K Number
    K080005
    Device Name
    SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701
    Manufacturer
    DING HWA CO., LTD.
    Date Cleared
    2008-04-24

    (113 days)

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

    DING HWA CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is to be used to remove fluids from the treated tracheotomy patient airway.
    Device Description
    SPARMAX Aspirator VC-701 and TC-2000V are the portable AC powered suction pumps. Each one consists of an on/off switch, a pump unit, a non detachable flexible power cord, collection jar, relief valve, pressure gauge, pressure adjustment knob, bacteria filter, suction tubing.
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