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

    SPIROPRO SPO2

    K Number: K031515 · Decision Nov 14, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    14
    Review Days
    184

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    Basic Information

    Device Name
    SPIROPRO SPO2
    K Number
    K031515
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Viasys Healthcare GmbH
    Date Received
    May 14, 2003
    Decision Date
    November 14, 2003
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    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
    DQA Oximeter

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    Other Clearances by Viasys Healthcare GmbH

    K Number Device Name
    K092324 SPIROPRO
    K091412 CLEAN PEAK FLOW METER
    K091505 COR12+
    K081823 MASTERSCREEN PAED - BABY BODY
    K080510 VIP PULMONARY FUNCTION SYSTEM
    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
    Search all 14 clearances from Viasys Healthcare GmbH →