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

    STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL

    K Number: K901301 · Decision May 31, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    21
    Review Days
    72

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    Basic Information

    Device Name
    STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL
    K Number
    K901301
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Automatic Liquid Packaging, Inc.
    Date Received
    March 20, 1990
    Decision Date
    May 31, 1990
    Product Code
    CAF
    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
    CAF Nebulizer (Direct Patient Interface)

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