BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    NRFit® Caps, Male and Female Neuraxial Tip Caps

    K Number: K201031 · Decision Dec 16, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    4
    Applicant Total
    7
    Review Days
    240

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    Basic Information

    Device Name
    NRFit® Caps, Male and Female Neuraxial Tip Caps
    K Number
    K201031
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    International Medical Industries, Inc.
    Date Received
    April 20, 2020
    Decision Date
    December 16, 2020
    Product Code
    QEH
    Advisory Committee
    General Hospital
    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
    QEH Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact

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