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

    INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K

    K Number: K002739 · Decision Sep 11, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    30
    Applicant Total
    505
    Review Days
    10

    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
    INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K
    K Number
    K002739
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baxter Healthcare Corp
    Date Received
    September 1, 2000
    Decision Date
    September 11, 2000
    Product Code
    MEA
    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
    MEA Pump, Infusion, Pca

    Similar 510(k) Clearances

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

    ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LifeCare PCA Infusion System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR

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

    Other Clearances by Baxter Healthcare Corp

    K Number Device Name
    K190910 PrisMax System Version 2
    K163530 PrisMax Control Unit
    K130531 ULTRAFUSE
    K132734 NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS
    K130245 LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO
    K123874 INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S
    K123868 INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET
    K121092 FLOWEASE [SUBCUTANEOUS] INFUSION SET
    K113227 NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
    K111217 ADDITIVE CAP
    Search all 505 clearances from Baxter Healthcare Corp →