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510(k) Data Aggregation

    K Number
    K152472
    Device Name
    Disposable Pressure Transducer
    Manufacturer
    ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD.
    Date Cleared
    2016-10-31

    (427 days)

    Product Code
    DRS
    Regulation Number
    870.2850
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Blood Pressure Transducer (DBPT) is intended for direct measurement and monitoring of fluid pressure.
    Device Description
    The Disposable Blood Pressure Transducer (DBPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The major components of the DBPT include the DBPT module that houses a ceramic, a luer connector with locking collar that can connect to an intravascular catheter, a transducer cable that can connect to a compatible pressure monitor and a stopcock for altering direction of fluid flow. The DBPT is provided sterile and for single use.
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    K Number
    K151498
    Device Name
    Breathing circuit bacterial/viral filter
    Manufacturer
    ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD.
    Date Cleared
    2015-12-18

    (197 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired and to add, maintain, retain moisture for the exhaled breathe of the patient. Use up to 24 hours. The Models of the filters are A501-1, A501-2, A501-3, and A501-4. The filters are intended for patient population that weighs greater than 10Kgs.
    Device Description
    Breathing circuit bacterial/viral filter has into two models: - 1) Bacterial/ viral filters; 2) Bacterial/viral filters HME. Breathing circuit bacterial/viral filters are available in multiple sizes and shapes, rectangular and round, and incorporate standard 15/22 mm connectors with a gas sampling luer port. The depth filter use electrostatic media for filtration and a foam media for the HME media.
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