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

    VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101

    K Number: K964360 · Decision Apr 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    89
    Applicant Total
    45
    Review Days
    154

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    Basic Information

    Device Name
    VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101
    K Number
    K964360
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1880
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Novametrix Medical Systems, Inc.
    Date Received
    November 1, 1996
    Decision Date
    April 4, 1997
    Product Code
    BZC
    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
    BZC Calculator, Pulmonary Function Data

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