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

    TEMPERATURE CONTROL & MONITOR

    K Number: K841402 · Decision Jun 11, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    29
    Applicant Total
    1
    Review Days
    69

    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
    TEMPERATURE CONTROL & MONITOR
    K Number
    K841402
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Sams, Inc.
    Date Received
    April 3, 1984
    Decision Date
    June 11, 1984
    Product Code
    DWC
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DWC Controller, Temperature, Cardiopulmonary Bypass

    Similar 510(k) Clearances

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

    Heater-Cooler System 3T

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Quantum Heater-Cooler

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Heater-Cooler System 3T

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SORIN FLEXTHERM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEATER-COOLER UNIT HCU 40

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all