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

    SPOT CHECK PULSE OXIMETER,512/513

    K Number: K032949 · Decision Aug 23, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    7
    Review Days
    336

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    Basic Information

    Device Name
    SPOT CHECK PULSE OXIMETER,512/513
    K Number
    K032949
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Respironics Novametrix, Inc.
    Date Received
    September 22, 2003
    Decision Date
    August 23, 2004
    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 Respironics Novametrix, Inc.

    K Number Device Name
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    K032971 TIDAL WAVE SP MODEL 710/715 AND 715
    K041450 MODIFICATION TO NICO WITH MARS, MODEL 7300
    K032755 MODEL 509M PULSE OXIMETER, MODEL 509M
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