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

    DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETER

    K Number: K874442 · Decision Feb 18, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    51
    Review Days
    113

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    Basic Information

    Device Name
    DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETER
    K Number
    K874442
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Critikon Company, LLC
    Date Received
    October 28, 1987
    Decision Date
    February 18, 1988
    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 Critikon Company, LLC

    K Number Device Name
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    K982342 DINAMAP MPS SELECT PORTABLE MONITOR
    K943709 DINAMAP PLUS VITAL SIGNS MONOITOR
    K942700 DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340
    K933404 CRITIKON CENTRAL STATIN MONITOR
    K933050 CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH
    K915697 CRITIKON VITAL SIGNS MODULE
    K921295 INTRAVENOUS CATHETERS MODIFICATIONS
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