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

    RemunityPRO™ Pump for Remodulin® (treprostinil) Injection

    K Number: K250357 · Decision Mar 11, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    10
    Review Days
    32

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    Basic Information

    Device Name
    RemunityPRO™ Pump for Remodulin® (treprostinil) Injection
    K Number
    K250357
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Deka Research & Development Corp.
    Date Received
    February 7, 2025
    Decision Date
    March 11, 2025
    Product Code
    FRN
    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
    FRN Pump, Infusion

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