BEUDAMED
    Product Code: KMG FDA class 2 21 CFR 880.6710

    Purifier, Water, Ultraviolet, Medical

    General Hospital

    An Ultraviolet Medical Water Purifier is a device used in healthcare settings that employs ultraviolet light irradiation to disinfect and purify water, inactivating bacteria, viruses, and other microorganisms to produce water suitable for medical or clinical use. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KMG and it is regulated under 21 CFR 880.6710 in the General Hospital specialty.

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    510(k)s
    9
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    4
    Years Active
    20

    Basic Information

    Product Code
    KMG
    Device Class
    FDA class 2
    Regulation Number
    880.6710
    Medical Specialty
    General Hospital
    Review Panel
    HO
    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 9 510(k) clearances via K numbers.

    K Number Device Name
    K012029 REMEDY MODEL 2Z12
    K832288 HEMOGLOBINOMETER
    K831253 LANCER HEMOGLOBIN ANALYZER REAGENTS
    K813050 AQUANOMICS, #MP4SF
    K813049 AQUANOMICS, #HHU100
    K813048 AQUANOMICS, #MP2SF
    K813047 AQUANOMICS, MINI 60L
    K813046 AQUANOMICS, #HHU60
    K813045 AQUANOMICS, #SP36SF

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.