BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    SINGLE USE MANOMETER

    K Number: K201666 · Decision Nov 13, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    77
    Applicant Total
    8
    Review Days
    147

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    Basic Information

    Device Name
    SINGLE USE MANOMETER
    K Number
    K201666
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2600
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Flexicare Medical Limited.
    Date Received
    June 19, 2020
    Decision Date
    November 13, 2020
    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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    K191909 HepaShield Bacterial Viral Breathing System Filter
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    K163300 ThermoShield HME Filter
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