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

    COLLINS DIGITAL PULMONARY MANOMETER

    K Number: K912946 · Decision Jan 15, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    5
    Applicant Total
    14
    Review Days
    194

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    Basic Information

    Device Name
    COLLINS DIGITAL PULMONARY MANOMETER
    K Number
    K912946
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1780
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Warren E. Collins, Inc.
    Date Received
    July 5, 1991
    Decision Date
    January 15, 1992
    Product Code
    BXR
    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
    BXR Meter, Airway Pressure (Inspiratory Force)

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    K803053 APEXLINE OF PULMONARY FUNCT. INSTRUM.
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