BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    SPRINGFUSOR 10R

    K Number: K910007 · Decision Nov 2, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    11
    Review Days
    1035

    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
    SPRINGFUSOR 10R
    K Number
    K910007
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Go Medical Industries Pty. , Ltd.
    Date Received
    January 2, 1991
    Decision Date
    November 2, 1993
    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 Go Medical Industries Pty. , Ltd.

    K Number Device Name
    K011055 THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS
    K002803 THE O'NEIL STERILE FIELD URINARY CATHETER KIT
    K000263 GO MEDICAL BALLOON INFUSION SYSTEM
    K900336 V SET
    K895594 SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE
    K890400 MODIFIED URINARY CATHETER INTRODUCER (UCI)
    K891465 OBSTETRIC CUP (MODIFICATION)
    K885283 ASPIRATING AND IRRIGATING CYSTS NEEDLES
    K850758 AMNIGLOVE & AMNICOT
    K840008 O'NEIL OBSTETRIC CUP
    Search all 11 clearances from Go Medical Industries Pty. , Ltd. →