BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇮 Finland

    AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT

    K Number: K943456 · Decision Oct 17, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    55
    Review Days
    91

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    Basic Information

    Device Name
    AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT
    K Number
    K943456
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Datex Division Instrumentarium Corp.
    Date Received
    July 18, 1994
    Decision Date
    October 17, 1994
    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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