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

    WALKAWAY TM 40

    K Number: K911400 · Decision Nov 19, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    44
    Applicant Total
    505
    Review Days
    235

    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
    WALKAWAY TM 40
    K Number
    K911400
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Baxter Healthcare Corp
    Date Received
    March 29, 1991
    Decision Date
    November 19, 1991
    Product Code
    LRG
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

    Similar 510(k) Clearances

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

    Thermo Scientific Sensititre ARIS HiQ System

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Thermo Scientific Sensititre ARIS HiQ System

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SENSITITRE OPTIREAD

    FDA 510(k)
    FDA Class 2 ·Microbiology

    AUTOREADER 2

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MICROSCAN(R) MICROSTREP PLUS(R)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MICROSCAN (R) MICROSTREP PLUS (R) PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology
    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 →