BEUDAMED
    Product Code: PGJ FDA class 2 21 CFR 870.2700

    Oximeter, Wellness

    Cardiovascular

    The Wellness Oximeter is a pulse oximeter intended for wellness use, providing non-medical-grade measurement of blood oxygen saturation for general health monitoring purposes. It is an FDA Class 2 device regulated under 21 CFR 870.2700, under enforcement discretion, within the Cardiovascular (CV) specialty with Anesthesiology (AN) panel review. The product code is PGJ. This device is not implantable and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    37
    Registration Numbers
    37
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    PGJ
    Device Class
    FDA class 2
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Review Panel
    AN
    Submission Type
    7

    Device Characteristics

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

    Definition

    Pulse oximeter intended for wellness use.

    FEI Numbers

    This FDA classification entry is associated with 37 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 37 registration numbers. Click on an entry to view related FDA registrations.