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510(k) Data Aggregation

    K Number
    K041154
    Device Name
    S-SCORT...JR QUICKDRAW, MODEL 2400
    Manufacturer
    SSCOR
    Date Cleared
    2004-05-18

    (15 days)

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

    SSCOR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The S-SCORT...Jr® Quickdraw, Model 2400 portable battery powered suction pump is a nonsterile reusable device, with a non-sterile single use disposable canister and integrated suction tip, that is to be used by professional personnel trained in Emergency Care techniques of constant suctioning to clear the airway by removing bodily fluids and particulate matter.
    Device Description
    The S-SCORT ...Jr® Quickdraw device is a design with added Subject Device Desertifications: a battery power level indicator, a custom non-sterile single use Uchents of user Inchary voltaons, a suction tip, an equally effective suction pump. The S-SCORT ... Jr® Quickdraw performance is significantly equivalent as the legally marketed devices. Components: The subject S-SCORT...Jr® Quickdraw consists of a high-specd diaphragm pump Componently "The bagger ed electric motor, an internal 12 VDC sealed lead acid rechargeable powered by an integrative circuit board with controls and signaling light-emitting diodes. All battery, and enoticolno of can o a molded plastic custom chassis. The 12 V battery and 12 V components are assemble to both operate and charge the device from any 12 VDC source. Charging may also take it possible to toing an external 110 VAC to 9 VDC power converter. Collection Canister: The S-SCORT ... Jr® Quickdraw uses a non-sterile single use disposable Concection Camster . The o OCON 11 is blow molded in a transparent plastic of Rigid Polyvinyl Chloride (RPVC) material that has been determined biocompatible (the RPVC does not contain Childride (11) VC) material that the canister sidewall has graduation marks that indicate the the plastioner DEFF you in canister has an integrated hydrophobic filter, which votune of content in oached in one capable of bacterial filtration to 99.98% with pore size of 20 microns and .200" in thickness.
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    K Number
    K964997
    Device Name
    S-SCORT (2500)
    Manufacturer
    SSCOR
    Date Cleared
    1997-03-05

    (79 days)

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

    SSCOR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The S-SCORT® Model 2500 is a portable suction pump to be used by professional personnel for constant suctioning. It can be used in hospital crash cart suction; patient transport; surgi-center back-up suction; emergency medical service; and home health care/nursing homes.
    Device Description
    The S-SCORT® Model 2500 is a portable suction pump to be used by professional personnel for constant suctioning. The unit comes equipped with a pump, regulator, battery, canister, suction tubing, suction tip with vent control, and carrying case.
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