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

    HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861

    K Number: K080424 · Decision May 28, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    26
    Applicant Total
    14
    Review Days
    103

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    Basic Information

    Device Name
    HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861
    K Number
    K080424
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hygia Health Services, Inc.
    Date Received
    February 15, 2008
    Decision Date
    May 28, 2008
    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 Hygia Health Services, Inc.

    K Number Device Name
    K100523 ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA
    K090074 HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS
    K053575 HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS
    K041867 HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N
    K032821 HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF
    K012715 HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II
    K021509 HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089
    K012650 HYGIA HEALTH SERVICES REPROCESSED NUTECH FOOT WRAP
    K012654 HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 40
    K012657 HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP
    Search all 14 clearances from Hygia Health Services, Inc. →