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

    BARRIER INTEGRITY MONITOR

    K Number: K915662 · Decision Jun 25, 1992
    View on FDA
    Classifications
    0
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    80
    Applicant Total
    1
    Review Days
    190

    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
    BARRIER INTEGRITY MONITOR
    K Number
    K915662
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Incomed, Inc.
    Date Received
    December 18, 1991
    Decision Date
    June 25, 1992
    Product Code
    LDQ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

    Similar 510(k) Clearances

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

    EC-7701 FLUID WARMING CABINET

    FDA 510(k)

    HOT SHOT FLUID WARMER IV FLUIDS

    FDA 510(k)

    PIV SYSTEM

    FDA 510(k)

    CONTROLLED TEMPERATURE CABINET SYSTEM

    FDA 510(k)

    ACU-HALT

    FDA 510(k)

    ACU-LAB

    FDA 510(k)