BEUDAMED
    Product Code: FZG FDA class 2 21 CFR 878.5070

    Apparatus, Air Handling, Bench

    General, Plastic Surgery

    The Apparatus, Air Handling, Bench (product code FZG) is a bench-top air handling unit used in surgical or clinical environments to manage airflow and help maintain a clean, controlled work area, typically used in operating rooms or procedure areas. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification demonstrating substantial equivalence to a legally marketed predicate device. The device is regulated under 21 CFR 878.5070 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.

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

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    Basic Information

    Product Code
    FZG
    Device Class
    FDA class 2
    Regulation Number
    878.5070
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    4

    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K760357 SKIN CLIP SYSTEM, DISPOSABLE (AVLOX ICI)

    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.