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

    ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)

    K Number: K972883 · Decision Feb 26, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    26
    Review Days
    205

    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
    ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)
    K Number
    K972883
    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
    Cypress Medical Products, Ltd.
    Date Received
    August 5, 1997
    Decision Date
    February 26, 1998
    Product Code
    FXX
    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
    FXX Mask, Surgical

    Similar 510(k) Clearances

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

    HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor

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

    Surgical Face Mask (Ear mount)

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

    Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)

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

    Disposable Surgical Face Mask (3P00B, C2900)

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

    Disposable Medical Face Mask

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

    KP Protective Face Mask

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

    Other Clearances by Cypress Medical Products, Ltd.

    K Number Device Name
    K021676 CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL
    K012282 STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE
    K972899 CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER
    K972849 ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)
    K952367 CYPRESS MEDICAL PRODUCTS VINYL EXAMINATION GLOVE
    K950254 CYPRESS MEDICAL PRODUCTS STERILE LATEX EXAMINATION GLOVE
    K950092 CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY
    K950109 CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY/WITH OUT CATHETER
    K945082 CYPRESS MEDICAL PRODUCTS STETHOSCOPE
    K921988 LACERATION REPAIR TRAY
    Search all 26 clearances from Cypress Medical Products, Ltd. →