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510(k) Data Aggregation

    K Number
    K201203
    Device Name
    Cliq Aspirator
    Manufacturer
    Anest Iwata Sparmax Co., Ltd.
    Date Cleared
    2020-09-03

    (122 days)

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

    Anest Iwata Sparmax Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DV-XXX aspirator provides a portable, battery-powered medical vacuum source. The DV-XXX can also be powered from a standard wall outlet with the use of an AC power adapter. It is intended for use in the home care or hospital environment.
    Device Description
    The DV-XXX is a portable AC/DC high vacuum / high flow suction pump. The DV-XXX can be powered from a standard wall outlet or from a rechargeable battery pack. The DV-XXX creates a negative pressure (vacuum) that draws fluids through tubing and into a collection container where the fluids are trapped for proper disposal. The device is comprised of a maintenance-free pump unit, an AC power adapter with power cord, an on/off switch, a pressure relief valve and pressure adjustment knob, a pressure gauge, an inline filter, intermediate tubing, and a rechargeable battery pack. Optional accessories which may be included with the unit include a collection canister and suction tubing. The DV-XXX produces a flow rate of up to 20 liters per minute, and has a maximum vacuum pressure of 620 mmHg. Housed in ABS plastic, the DV-XXX 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-XXX must only be used on the order of a physician.
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