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

    ZEE LIFE SUPPORT AIR PANTS

    K Number: K812564 · Decision Oct 23, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    3
    Applicant Total
    8
    Review Days
    45

    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
    ZEE LIFE SUPPORT AIR PANTS
    K Number
    K812564
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Zee Medical Products Co., Inc.
    Date Received
    September 8, 1981
    Decision Date
    October 23, 1981
    Product Code
    LHX
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LHX Trousers, Anti-Shock

    Similar 510(k) Clearances

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

    GLADIATOR ANTISHOCK PANTS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TROUSERS, PNEUMATIC, ANTI-SHOCK THREE BLADDERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BP TRAUMA AIR PANTS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Zee Medical Products Co., Inc.

    K Number Device Name
    K823501 ZEE SPHYGMOMANOMETER
    K813156 ULTRA-WIDE SAFETY SPECTACLE FRAME
    K813016 ZEE TRACTION SPLINT
    K812814 ZEE SURGICAL INSTRUMENTS
    K812342 ZEE EXTRICATION DEVICE
    K812284 ZEE ELECTRODE-GEL
    K812022 ZEE MANUAL RESUSCITATOR