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

    JEMSDAL MASK

    K Number: K942907 · Decision Aug 31, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    54
    Applicant Total
    1
    Review Days
    71

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    Basic Information

    Device Name
    JEMSDAL MASK
    K Number
    K942907
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5580
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Respan Products, Inc.
    Date Received
    June 21, 1994
    Decision Date
    August 31, 1994
    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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