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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR

    K Number: K122702 · Decision Mar 18, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    195

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    Basic Information

    Device Name
    BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR
    K Number
    K122702
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Filligent Limited
    Date Received
    September 4, 2012
    Decision Date
    March 18, 2013
    Product Code
    ONT
    Advisory Committee
    General, Plastic Surgery
    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
    ONT N95 Respirator With Antimicrobial/Antiviral Agent

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    Other Clearances by Filligent Limited

    K Number Device Name
    K101128 BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013