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

    MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE

    K Number: K111007 · Decision Jun 8, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    4
    Review Days
    58

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    Basic Information

    Device Name
    MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE
    K Number
    K111007
    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
    April 11, 2011
    Decision Date
    June 8, 2011
    Product Code
    NMD
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NMD Oximeter, Tissue Saturation, Reprocessed

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NMD), ordered by most recent decision date.

    ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Midwest Reprocessing Center, LLC

    K Number Device Name
    K101280 MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE
    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