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

    ISOLAIR APR TYPE N95

    K Number: K960778 · Decision May 9, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    224
    Registration Numbers
    224
    Same Product Code
    34
    Applicant Total
    8
    Review Days
    73

    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
    ISOLAIR APR TYPE N95
    K Number
    K960778
    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
    Louis M. Gerson Co., Inc.
    Date Received
    February 26, 1996
    Decision Date
    May 9, 1996
    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

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

    K Number Device Name
    K061375 RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730
    K050193 GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR
    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