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

    INTRA-ALERT

    K Number: K781297 · Decision Oct 25, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    38
    Applicant Total
    2
    Review Days
    90

    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
    INTRA-ALERT
    K Number
    K781297
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2420
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Pan-Tech Research, Inc.
    Date Received
    July 27, 1978
    Decision Date
    October 25, 1978
    Product Code
    FLN
    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
    FLN Monitor, Electric For Gravity Flow Infusion Systems

    Similar 510(k) Clearances

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

    DripAssist Plus

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DripAssist

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FLUID LEVEL MONITOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LOW FLUID ALARM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ISSYS DRUG FLOW MONITOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LEVELERT II FLUID LEVEL SENSOR

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

    Other Clearances by Pan-Tech Research, Inc.

    K Number Device Name
    K820759 VEIN-SHIELD