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

    MANOMETER SET C.V.P. #S 298/299

    K Number: K830910 · Decision Apr 5, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    8
    Applicant Total
    20
    Review Days
    15

    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
    MANOMETER SET C.V.P. #S 298/299
    K Number
    K830910
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1140
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Exco, Inc.
    Date Received
    March 21, 1983
    Decision Date
    April 5, 1983
    Product Code
    KRK
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KRK Manometer, Blood-Pressure, Venous

    Similar 510(k) Clearances

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

    UST-5268P-5 TRANSDUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CENTRAL VENOUS PRESSURE MANOMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SCHNEIDER-SHILEY PRESSURE MANOMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDIFIX

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

    Other Clearances by Exco, Inc.

    K Number Device Name
    K844203 ENTERNAL FEEDING TUBE SILICONE-EF401, 402 & 403
    K844175 ENTERNAL FEEDING TUBE-POLYURETHANE EF504
    K844174 FLEXIBLE STAINLESS STEEL STYLET FOR ENTERNAL FEEDI
    K832628 VYGON THORACIC DRAINAGE-VARIOUS #'S
    K831802 LIFE VAC #2191 & 2192
    K833079 CENTRACATH #130,135 & 137-HEMOCATH #
    K822879 ENTERAL NUTRITION 1
    K822691 VYGON EPIDURAL ANAESTHESIA TRAY
    K822836 MICROFLEX-VENOFLUX
    K822724 SUCTION TUBES
    Search all 20 clearances from Exco, Inc. →