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

    THERMOMETER SHEATHES, STERILE (GLASS)

    K Number: K870285 · Decision Feb 12, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    32
    Applicant Total
    16
    Review Days
    16

    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
    THERMOMETER SHEATHES, STERILE (GLASS)
    K Number
    K870285
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2920
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    The Medical Group, Inc.
    Date Received
    January 27, 1987
    Decision Date
    February 12, 1987
    Product Code
    FLK
    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
    FLK Thermometer, Clinical Mercury

    Similar 510(k) Clearances

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

    AMSINO CLINICAL THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GERATHERM MERCUIRY FREE CLINICAL THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    KENTEMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CLINICAL GLASS THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDIAID UNIVERSAL THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AMG MED BRAND CLINICAL GLASS THERMOMETER

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

    Other Clearances by The Medical Group, Inc.

    K Number Device Name
    K911246 THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2
    K901295 PULMONAIR 40 PATIENT MANAGEMENT SYSTEM
    K881843 PEDIATRIC HOSPITAL BED
    K881844 MAGNUM 800(TM) MANAGEMENT SYSTEM
    K870282 4 X 4 SPONGES, NON-STERILE
    K870284 TRIANGULAR BANDAGE
    K870283 3 X 3 SPONGES, NON-STERILE
    K863766 DISPOSABLE MOUTH MIRRORS, SINGLE USE ONLY
    K863767 GLASS MOUTH MIRRORS, REUSABLE
    K863769 EVACUATOR TIPS
    Search all 16 clearances from The Medical Group, Inc. →