BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    MASTERSCREEN PAED - BABY BODY

    K Number: K081823 · Decision May 18, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    10
    Applicant Total
    14
    Review Days
    325

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    Basic Information

    Device Name
    MASTERSCREEN PAED - BABY BODY
    K Number
    K081823
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1750
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Viasys Healthcare GmbH
    Date Received
    June 27, 2008
    Decision Date
    May 18, 2009
    Product Code
    CCM
    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
    CCM Plethysmograph, Pressure

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    Other Clearances by Viasys Healthcare GmbH

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    K080734 FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT
    K072061 MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY
    K072323 MASTERSCREEN & OXYCON CPX
    K071753 MASTERSCREEN PNEUMO & MASTERSCOPE
    K062011 MODIFICATION TO FLOWSCREEN
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