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

    ALARIS SYSTEM WITH GUARDRAILS SUITE MX

    K Number: K133532 · Decision Aug 21, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    7
    Review Days
    276

    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
    ALARIS SYSTEM WITH GUARDRAILS SUITE MX
    K Number
    K133532
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carefusion 303, Inc.
    Date Received
    November 18, 2013
    Decision Date
    August 21, 2014
    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 Carefusion 303, Inc.

    K Number Device Name
    K243855 BD Alaris Infusion System with Guardrails Suite MX
    K211218 BD Alaris System with Guardrails Suite MX v12.1.2
    K171957 MaxZero Extension Sets with Needless Connector
    K163316 Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System
    K110535 ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION
    K110809 WIRELESS MONITORING SYSTEM