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

    INFUSION PUMP, PEDIATRIC MODEL 301

    K Number: K781171 · Decision Aug 10, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    43
    Review Days
    28

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    INFUSION PUMP, PEDIATRIC MODEL 301
    K Number
    K781171
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Imed Corp.
    Date Received
    July 13, 1978
    Decision Date
    August 10, 1978
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FRN), ordered by most recent decision date.

    FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SIGMA Spectrum Infusion Pump with Master Drug Library

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MRidium 3870 MRI Infusion Pump System (3870)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD Alaris Infusion System with Guardrails Suite MX

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Plum Solo™ Precision IV Pump

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Imed Corp.

    K Number Device Name
    K960512 GEMINI PC-ITX
    K953896 THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS
    K950153 VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES
    K951922 ADMINISTRATION SETS WITH BALL FLOAT
    K950419 THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS
    K944320 VENTED/NON-VENTED GEMINI ADMINISTRATION SET
    K945070 VERSASAE PLASTIC CANNULA- 11 GAUGE
    K931173 PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/ABV PUMP CH
    K933144 GEMINI VOLUMETRIC INFUSION PUMP/CONTROLLER
    K924718 SHROUDED NEEDLE DEVICES
    Search all 43 clearances from Imed Corp. →