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

    VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0

    K Number: K102377 · Decision Nov 18, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    77
    Applicant Total
    7
    Review Days
    90

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    Basic Information

    Device Name
    VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0
    K Number
    K102377
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2600
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    A Plus Medical
    Date Received
    August 20, 2010
    Decision Date
    November 18, 2010
    Product Code
    CAP
    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
    CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

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