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

    SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283

    K Number: K882955 · Decision Jan 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    57
    Review Days
    561

    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
    SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283
    K Number
    K882955
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Kontron Instruments, Inc.
    Date Received
    July 14, 1988
    Decision Date
    January 26, 1990
    Product Code
    DXN
    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
    DXN System, Measurement, Blood-Pressure, Non-Invasive

    Similar 510(k) Clearances

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

    Wrist Blood Pressure Monitor (XW-05)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VicorderCS (VCS-SYS-1100)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Upper arm electronic blood pressure monitor (XB-01)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Blood Pressure Monitor (W06LT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)

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

    Other Clearances by Kontron Instruments, Inc.

    K Number Device Name
    K932268 MODIFICATIONS TO INTRA-AORTIC BALLOONS
    K925248 MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS
    K923603 INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION
    K905313 KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II
    K903344 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)
    K896437 KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM
    K892222 9.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON
    K896386 MINIMON 7133B PATIENT MONITOR
    K896417 KONTRON KOLORMON 7250 PATIENT MONITOR
    K895425 MINIMON 7137B PATIENT MONITOR
    Search all 57 clearances from Kontron Instruments, Inc. →