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

    ANALOR FOUR-DENTAL MODEL

    K Number: K801100 · Decision May 28, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    187
    Applicant Total
    6
    Review Days
    19

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    Basic Information

    Device Name
    ANALOR FOUR-DENTAL MODEL
    K Number
    K801100
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5160
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Narco Mckesson Co.
    Date Received
    May 9, 1980
    Decision Date
    May 28, 1980
    Product Code
    BSZ
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BSZ Gas-Machine, Anesthesia

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    Other Clearances by Narco Mckesson Co.

    K Number Device Name
    K801101 ANALOR FOUR-ORAL SURGERY MODEL
    K801102 COMPALOR-ORAL SURGERY MODEL
    K801103 COMPALOR-DENTAL MODEL
    K790456 SERIES 7000
    K781492 SERIES 7000 GAS MACHINE