BEUDAMED
    Product Code: DPZ FDA class 2 21 CFR 870.2710

    Oximeter, Ear

    Cardiovascular

    The Ear Oximeter is a non-invasive diagnostic device that measures the oxygen saturation of hemoglobin in blood by attaching a sensor to the ear, used to monitor patients' oxygenation status in clinical and monitoring settings. It is a Class 2 device requiring a 510(k) premarket notification before marketing. The product code is DPZ, regulated under 21 CFR 870.2710, within the Cardiovascular medical specialty. No special regulatory flags apply.

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    510(k)s
    11
    FEI Numbers
    54
    Registration Numbers
    54
    Unique Applicants
    10
    Years Active
    24

    Basic Information

    Product Code
    DPZ
    Device Class
    FDA class 2
    Regulation Number
    870.2710
    Medical Specialty
    Cardiovascular
    Review Panel
    AN
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 11 510(k) clearances via K numbers.

    K Number Device Name
    K042675 FLEXI-STAT SP02 EAR SENSOR
    K040831 DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
    K012333 FLEXI-SITE SP02 EAR SENSOR
    K010718 FLEXI-SITE SP02 EAR SENSOR
    K944760 DURA-Y OXYGEN TRANSDUCER, EAR CLIP
    K942752 MARQUETTE EAR PROBE SENSOR
    K914595 PULSE RATE MONITOR
    K862426 PULSE OXIMETER
    K845051 VITALOG PMS-8
    K850494 OHMEDA BIOX 3700 PULSE OXIMETER
    K810363 EAR OXIMETER

    FEI Numbers

    This FDA classification entry is associated with 54 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 54 registration numbers. Click on an entry to view related FDA registrations.