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

    FLEXI-STAT SP02 EAR SENSOR

    K Number: K042675 · Decision Dec 6, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    10
    Applicant Total
    6
    Review Days
    68

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    Basic Information

    Device Name
    FLEXI-STAT SP02 EAR SENSOR
    K Number
    K042675
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2710
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Elekon Industries U.S.A., Inc.
    Date Received
    September 29, 2004
    Decision Date
    December 6, 2004
    Product Code
    DPZ
    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
    DPZ Oximeter, Ear

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    Other Clearances by Elekon Industries U.S.A., Inc.

    K Number Device Name
    K042705 DISPOSABLE NON-ADHESIVE SPO2 SENSORS
    K042704 REUSABLE FINGER CLIP SPO2 SENSORS
    K041522 FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS
    K041647 FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE)
    K041644 FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)