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

    RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE

    K Number: K111773 · Decision Nov 16, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    26
    Applicant Total
    9
    Review Days
    146

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    Basic Information

    Device Name
    RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE
    K Number
    K111773
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Renu Medical, Inc.
    Date Received
    June 23, 2011
    Decision Date
    November 16, 2011
    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 Renu Medical, Inc.

    K Number Device Name
    K203847 Reprocessed Tri Pulse Compression Garment
    K121145 RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME
    K093658 RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS FOOT GARMENTS
    K081927 RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO
    K072194 RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25
    K063661 RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20
    K051227 RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1
    K031559 RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES