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

    MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE

    K Number: K101280 · Decision Oct 7, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    26
    Applicant Total
    4
    Review Days
    154

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    Basic Information

    Device Name
    MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE
    K Number
    K101280
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Midwest Reprocessing Center, LLC
    Date Received
    May 6, 2010
    Decision Date
    October 7, 2010
    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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    Other Clearances by Midwest Reprocessing Center, LLC

    K Number Device Name
    K111007 MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE
    K101702 MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS
    K101330 MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLE