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

    MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85

    K Number: K884436 · Decision Dec 2, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    42

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    Basic Information

    Device Name
    MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85
    K Number
    K884436
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9700
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Harris Mfg. Co.
    Date Received
    October 21, 1988
    Decision Date
    December 2, 1988
    Product Code
    KSE
    Advisory Committee
    Hematology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KSE Refrigerator, Freezer, Blood Storage

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