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

    CAPNOMASK

    K Number: K131339 · Decision Nov 25, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    4
    Review Days
    200

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    Basic Information

    Device Name
    CAPNOMASK
    K Number
    K131339
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mediplus , Ltd.
    Date Received
    May 9, 2013
    Decision Date
    November 25, 2013
    Product Code
    CCK
    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
    CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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    Other Clearances by Mediplus , Ltd.

    K Number Device Name
    K132890 SUPRAPUBIC CATHETER AND INTRODUCER SET
    K031617 MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER
    K013704 MEDIPLUS SINGLE USE GI MANOMETRY CATHETER