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

    SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150

    K Number: K100139 · Decision May 4, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    224
    Registration Numbers
    224
    Same Product Code
    34
    Applicant Total
    1
    Review Days
    105

    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
    SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150
    K Number
    K100139
    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
    Safelife Corp.
    Date Received
    January 19, 2010
    Decision Date
    May 4, 2010
    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

    Similar 510(k) Clearances

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

    Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Master-Frank N95 Particulate Respirator

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all