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

    KELLER PULSE OXIMETER, MODEL 850+

    K Number: K982331 · Decision Sep 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    6
    Review Days
    71

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    Basic Information

    Device Name
    KELLER PULSE OXIMETER, MODEL 850+
    K Number
    K982331
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Keller Medical Specialties Products, Inc.
    Date Received
    July 2, 1998
    Decision Date
    September 11, 1998
    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 Keller Medical Specialties Products, Inc.

    K Number Device Name
    K990648 KELLER VITAL SIGNS MONITOR, KMS 890+
    K914576 KELLER CARDIAC MONITOR MEDIL KMS870
    K910262 KELLER VITAL SIGNS MONITOR - KMS-890
    K903437 DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER
    K895987 KELLER PULSE OXIMETER - KMS 850