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

    WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK

    K Number: K953464 · Decision Sep 18, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    54
    Applicant Total
    8
    Review Days
    56

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    Basic Information

    Device Name
    WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK
    K Number
    K953464
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5580
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Westmed, Inc.
    Date Received
    July 24, 1995
    Decision Date
    September 18, 1995
    Product Code
    BYG
    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
    BYG Mask, Oxygen

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