BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    DORA Tubing Sets for Hemodialysis

    K Number: K161582 · Decision Jun 16, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    76
    Applicant Total
    7
    Review Days
    373

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    Basic Information

    Device Name
    DORA Tubing Sets for Hemodialysis
    K Number
    K161582
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bain Medical Equipment (Guangzhou) Co., Ltd.
    Date Received
    June 8, 2016
    Decision Date
    June 16, 2017
    Product Code
    FJK
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

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    Other Clearances by Bain Medical Equipment (Guangzhou) Co., Ltd.

    K Number Device Name
    K252423 NovaLine Tubing Set for Hemodialysis (BL 124)
    K240164 NovaLine SP-C35 Transducer Protector (956007)
    K213015 DORA Disposable A.V. Fistula Needle Sets
    K201866 NovaLine Tubing Sets for Hemodialysis
    K203524 Surgical Masks
    K163025 DORA Disposable A.V. Fistula Needle Sets