BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    T34L SYRINGE DRIVER

    K Number: K080954 · Decision May 16, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    9
    Review Days
    43

    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
    T34L SYRINGE DRIVER
    K Number
    K080954
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Caesarea Medical Electronics , Ltd.
    Date Received
    April 3, 2008
    Decision Date
    May 16, 2008
    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 Caesarea Medical Electronics , Ltd.

    K Number Device Name
    K070235 BODYGUARD PAIN MANAGER INFUSION SYSTEM
    K070718 MODIFICATION TO: BODYGUARD INFUSION SYSTEM
    K061325 BODYGAURD PAIN MANAGER INFUSION SYSTEM
    K060479 MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM
    K050800 NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS
    K042696 BODYGUARD INFUSION PUMP SYSTEM
    K040957 NOA III ENTERAL NUTRITION PUMP
    K031749 BODYGUARD INFUSION SYSTEM