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

    CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L

    K Number: K012600 · Decision Jul 3, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    26
    Applicant Total
    14
    Review Days
    324

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    Basic Information

    Device Name
    CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L
    K Number
    K012600
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clearmedical, Inc.
    Date Received
    August 13, 2001
    Decision Date
    July 3, 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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    Other Clearances by Clearmedical, Inc.

    K Number Device Name
    K033578 REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS
    K033579 REPROCESSED MULTIPLE CLIP APPLIERS
    K033591 REPROCESSED TROCARS
    K033592 REPROCESSED SURGICAL SCISSORS AND GRASPERS
    K033593 REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS
    K031416 CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF; CLEARMEDICAL/WELCH ALLYN BLOOD PRESSURE CUFF
    K012622 CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20
    K012609 CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25
    K012601 CLEARMEDICAL/AIRCAST VENAFLOW CALF CUFF, CLEARMEDICAL AIRCAST XL VENAFLOW CALF CUFF, CLEARMEDICAL/AIRCAST VENAFLOW THIGH
    K012621 CLEARMEDICAL/HENTLEIGH DEEP VEIN THROMBOSIS (DVT) GARMENT
    Search all 14 clearances from Clearmedical, Inc. →