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

    EAR OXIMETER

    K Number: K810363 · Decision Feb 27, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    10
    Applicant Total
    37
    Review Days
    16

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    Basic Information

    Device Name
    EAR OXIMETER
    K Number
    K810363
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2710
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Bio-Tek Instruments, Inc.
    Date Received
    February 11, 1981
    Decision Date
    February 27, 1981
    Product Code
    DPZ
    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
    DPZ Oximeter, Ear

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