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

    IMS MINIATURE VOLUMETRIC INFUSION PUMP

    K Number: K830454 · Decision Mar 31, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    16
    Review Days
    44

    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
    IMS MINIATURE VOLUMETRIC INFUSION PUMP
    K Number
    K830454
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Ziehm International, Inc.
    Date Received
    February 15, 1983
    Decision Date
    March 31, 1983
    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 Ziehm International, Inc.

    K Number Device Name
    K011292 ZIEHM VISION
    K910455 IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTOR
    K902196 MODIFIED STICK-GARD SAFETY NEEDLE
    K894021 MOBILE X-RAY UNIT
    K894041 PUMP-JECT SYRINGE WITH LUER-LOCK
    K890620 STICK-GARD SAFETY NEEDLE
    K882133 MAMMO M
    K843311 IV ADMIN. SET FOR MVP 1 INFUSION PUMP
    K842263 MTP E.V. INFUSION PUMP
    K831407 CARDIAC OUTPUT COMPUTER
    Search all 16 clearances from Ziehm International, Inc. →