BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    STERI-AID KIT

    K Number: K963049 · Decision Nov 12, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    13
    Applicant Total
    1
    Review Days
    110

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    Basic Information

    Device Name
    STERI-AID KIT
    K Number
    K963049
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.2900
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Steri-Aid, Inc.
    Date Received
    July 25, 1996
    Decision Date
    November 12, 1996
    Product Code
    FQZ
    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
    FQZ Thermometer, Clinical Color Change

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