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

    FLUID WARMER

    K Number: K803249 · Decision May 21, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    74
    Applicant Total
    5
    Review Days
    149

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    Basic Information

    Device Name
    FLUID WARMER
    K Number
    K803249
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Datachem, Inc.
    Date Received
    December 23, 1980
    Decision Date
    May 21, 1981
    Product Code
    LGZ
    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
    LGZ Warmer, Thermal, Infusion Fluid

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    Other Clearances by Datachem, Inc.

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    K834534 APSARA ANALYZER
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