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

    EQUI-GUARD (ASPIRATOR FILTER)

    K Number: K902089 · Decision Jul 6, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    193
    Registration Numbers
    193
    Same Product Code
    86
    Applicant Total
    5
    Review Days
    58

    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
    EQUI-GUARD (ASPIRATOR FILTER)
    K Number
    K902089
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Equi-Tron Mfg., Inc.
    Date Received
    May 9, 1990
    Decision Date
    July 6, 1990
    Product Code
    GCX
    Advisory Committee
    General Hospital
    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
    GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered

    Similar 510(k) Clearances

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

    STRYKER CASSETTE PUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SUCTION INSTRUMENTATION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CHASE SUCKER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDI-VAC FLEXI-CLEAR SUCTION HANDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CURITY THORACENTESIS TRAY

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Equi-Tron Mfg., Inc.

    K Number Device Name
    K962763 2000 MODULAR THIRTY-NINE
    K903904 SERIES 2000 ADJUSTABLE BED
    K903905 SERIES 9000 LIFT-RECLINE CHAIR
    K894831 PORTABLE AIR COMPRESSOR MODEL NUMBER 8125