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

    ASPIRE

    K Number: K936110 · Decision Mar 23, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    79
    Applicant Total
    3
    Review Days
    455

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    Basic Information

    Device Name
    ASPIRE
    K Number
    K936110
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1860
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dura Pharmaceuticals, Inc.
    Date Received
    December 23, 1993
    Decision Date
    March 23, 1995
    Product Code
    BZH
    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
    BZH Meter, Peak Flow, Spirometry

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    Other Clearances by Dura Pharmaceuticals, Inc.

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