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

    MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER

    K Number: K875322 · Decision Mar 28, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    8
    Applicant Total
    9
    Review Days
    90

    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
    MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER
    K Number
    K875322
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1140
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Schneider-Shilley (Usa)
    Date Received
    December 29, 1987
    Decision Date
    March 28, 1988
    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

    SCHNEIDER-SHILEY PRESSURE MANOMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

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

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDIFIX

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

    Other Clearances by Schneider-Shilley (Usa)

    K Number Device Name
    K882826 SOFTRAC-PTA PERIPHERAL DILATATION CATHETER
    K875175 MODIFIED PERIPHERAL DILATATION CATHETERS
    K881197 SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETER
    K875323 MODIFIED SCHNEIDER-SHILEY WIRE TORQUER
    K875324 MODIFIED SCHNEIDER SHILEY INFLATION SYRINGES
    K875327 MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT
    K875325 MODIFIED OCCLUDER/FLUSHING CATHETER STOPCOCK
    K875326 MODIFIED SCHNEIDER-SHILEY FLUSHING CATHETER