BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇬 Singapore

    Bevel Up Holder

    K Number: K193074 · Decision Apr 21, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    5
    Review Days
    169

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    Basic Information

    Device Name
    Bevel Up Holder
    K Number
    K193074
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nsp Tech Pte, Ltd.
    Date Received
    November 4, 2019
    Decision Date
    April 21, 2020
    Product Code
    JKA
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

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    Other Clearances by Nsp Tech Pte, Ltd.

    K Number Device Name
    K221783 SafetiCET Safety Lancet
    K221604 SafetiHeel, MediHeel, Novaplus
    K181754 Blood Collection Accessory (BUCA)
    K181743 Blood Transfer Accessory (BTA)