BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MA-40, MA-112

    K Number: K223835 · Decision Sep 18, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    52
    Applicant Total
    1
    Review Days
    270

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MA-40, MA-112
    K Number
    K223835
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5045
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medify Air, LLC
    Date Received
    December 22, 2022
    Decision Date
    September 18, 2023
    Product Code
    FRF
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FRF Cleaner, Air, Medical Recirculating

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FRF), ordered by most recent decision date.

    Biomoneta Avata Rx

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CerroZone Mini

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Airdog X8 Air Purifier (KJ800F-X8)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RIA Safeguard

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Qorda QD1

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all