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

    VANGUARD REPROCESSED PULSE OXIMETER SENSORS

    K Number: K012344 · Decision Oct 4, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    26
    Applicant Total
    33
    Review Days
    437

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    Basic Information

    Device Name
    VANGUARD REPROCESSED PULSE OXIMETER SENSORS
    K Number
    K012344
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vanguard Medical Concepts, Inc.
    Date Received
    July 24, 2001
    Decision Date
    October 4, 2002
    Product Code
    NLF
    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
    NLF Oximeter, Reprocessed

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