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

    GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR

    K Number: K050193 · Decision Apr 11, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    224
    Registration Numbers
    224
    Same Product Code
    34
    Applicant Total
    8
    Review Days
    74

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    Basic Information

    Device Name
    GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR
    K Number
    K050193
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Louis M. Gerson Co., Inc.
    Date Received
    January 27, 2005
    Decision Date
    April 11, 2005
    Product Code
    MSH
    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
    MSH Respirator, Surgical

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    Other Clearances by Louis M. Gerson Co., Inc.

    K Number Device Name
    K061375 RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730
    K960778 ISOLAIR APR TYPE N95
    K925185 ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/EARLOOP MAS
    K931288 ISOLAIR 2 FULL FACE SPLASH GUARD
    K922507 GERSON ISOLAIR APR PARTICULATE SURGICAL MASK
    K881910 LABELING CHANGE TO SURGICAL FACE MASK
    K802373 SURGICAL FACE MASK