BEUDAMED
    Product Code: OLK FDA class 2 21 CFR 870.2700

    Pulse Oximeter For Over-The-Counter Use

    Cardiovascular

    The Pulse Oximeter For Over-The-Counter Use (product code OLK) is a Class 2 cardiovascular device regulated under 21 CFR 870.2700, cleared through the 510(k) pathway. It is a non-wearable, fingertip pulse oximeter intended for over-the-counter consumer use for non-continuous monitoring of blood oxygen saturation. The device is reviewed by the Anesthesiology panel and is not an implant or life-sustaining device.

    View on FDA
    510(k)s
    2
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    2
    Years Active
    1

    Basic Information

    Product Code
    OLK
    Device Class
    FDA class 2
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Review Panel
    AN
    Submission Type
    1

    Device Characteristics

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

    Definition

    Non-wearable, fingertip pulse oximeter intended for over-the-counter use for non-continuous monitoring

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K211498 Nonin OTC Pulse Oximeter Model 3250
    K214115 MightySat -OTC

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.