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

    HORIZON 2000 PULSE OXIMETRY (SAO2) MONITOR CAPABIL

    K Number: K901774 · Decision May 22, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    34
    Review Days
    33

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    Basic Information

    Device Name
    HORIZON 2000 PULSE OXIMETRY (SAO2) MONITOR CAPABIL
    K Number
    K901774
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Mennen Medical, Inc.
    Date Received
    April 19, 1990
    Decision Date
    May 22, 1990
    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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    K940081 MERCURY
    K940415 HORIZON 9000 WS
    K920915 CAPNOMED 100 STAND-ALONE ETCO2 MODULE
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