BEUDAMED
    Product Code: OCH FDA class 2 21 CFR 870.2700

    Oximeter, Infrared, Sporting, Aviation

    Cardiovascular

    The Infrared Oximeter for Sporting and Aviation Activities (product code OCH) is a cardiovascular monitoring device solely intended for use during sporting and aviation activities to monitor heart rate during exercise, rather than for clinical diagnostic or treatment purposes. It uses infrared technology to detect physiological signals at the periphery. This device is FDA Class 2 under regulation 870.2700 in the Cardiovascular specialty; it falls under an enforcement discretion category (submission type 7) and is not subject to standard premarket notification requirements under the convenience kit/enforcement discretion framework. It carries no implant or life-sustaining flags.

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    510(k)s
    0
    FEI Numbers
    53
    Registration Numbers
    53
    Unique Applicants
    0
    Years Active
    —

    Basic Information

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

    Device Characteristics

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

    Definition

    Solely for use with sporting and aviation activities. Intended to monitor heart rate during exercise.

    FEI Numbers

    This FDA classification entry is associated with 53 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 53 registration numbers. Click on an entry to view related FDA registrations.