BEUDAMED
    Product Code: QKY FDA not classified

    Decontamination Systems For N95 Respirators

    Unknown

    Decontamination Systems For N95 Respirators are not-classified devices intended to decontaminate compatible N95 or N95-equivalent respirators for reuse by healthcare professionals during the declared COVID-19 public health emergency, authorized under Emergency Use Authorization. The product code is QKY, reviewed by the General Hospital panel, with no regulation number assigned. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    QKY
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    HO
    Submission Type
    8

    Device Characteristics

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

    Definition

    Device intended to decontaminate compatible N95 or N95-equivalent respirators for their reuse by healthcare professionals during the declared public health emergency.

    Unclassified Reason

    11

    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.