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

    NovaLine SP-C35 Transducer Protector (956007)

    K Number: K240164 · Decision Jun 28, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    34
    Applicant Total
    7
    Review Days
    158

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    Basic Information

    Device Name
    NovaLine SP-C35 Transducer Protector (956007)
    K Number
    K240164
    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
    January 22, 2024
    Decision Date
    June 28, 2024
    Product Code
    FIB
    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
    FIB Protector, Transducer, Dialysis

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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)
    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
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