BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PENLON JUMBO CARBON DIOXIDE ABSORBER

    K Number: K801255 · Decision Jun 4, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    7
    Applicant Total
    10
    Review Days
    7

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    Basic Information

    Device Name
    PENLON JUMBO CARBON DIOXIDE ABSORBER
    K Number
    K801255
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5310
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Penlon, Inc.
    Date Received
    May 28, 1980
    Decision Date
    June 4, 1980
    Product Code
    BSF
    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
    BSF Absorber, Carbon-Dioxide

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