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

    MCGAW/DROP WATCH FLOW MONITOR

    K Number: K853549 · Decision Nov 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    38
    Applicant Total
    13
    Review Days
    78

    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
    MCGAW/DROP WATCH FLOW MONITOR
    K Number
    K853549
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2420
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    American Mcgaw
    Date Received
    August 26, 1985
    Decision Date
    November 12, 1985
    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 American Mcgaw

    K Number Device Name
    K843639 ADD-A-VIAL SOLUTION TRANSFER DEVICE
    K843954 MIXING CONTAINER
    K841729 ACCUPRO ENTERAL FEEDING PUMP
    K840212 CONCENTRATED PLATELET ADMIN. SET
    K840388 PAB IV CONTAINER
    K831716 CAPD - CATHETER ADAPTER
    K822240 ETHYLENE OXIDE STERILIZ. PARAMETRIC REL.
    K820133 MCGAW FAT EMULSION SET
    K813092 ACCUPRO I.V. ADMINISTRATION SET
    K810683 CAPD CATHETER ADAPTER
    Search all 13 clearances from American Mcgaw →