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

    DISPOS-A-CARE THERMOMETER SHEATH

    K Number: K770125 · Decision Mar 14, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    32
    Applicant Total
    33
    Review Days
    52

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    Basic Information

    Device Name
    DISPOS-A-CARE THERMOMETER SHEATH
    K Number
    K770125
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2920
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Chesebrough-Pond'S U.S.A. Co.
    Date Received
    January 21, 1977
    Decision Date
    March 14, 1977
    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

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