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

    NON-INVASIVE BLOOD PRESSURE MODULE

    K Number: K875265 · Decision Feb 29, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    20
    Review Days
    69

    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
    NON-INVASIVE BLOOD PRESSURE MODULE
    K Number
    K875265
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Ppg Industries, Inc.
    Date Received
    December 22, 1987
    Decision Date
    February 29, 1988
    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 Ppg Industries, Inc.

    K Number Device Name
    K922631 STATPAL II BLOOD GAS ANALYSIS SYSTEM
    K913358 MIDAS SYSTEM(TM) 5100 PHYSIOLOG MONIT/RECORD SYST
    K914560 STAT PAL SENSYR SYRINGE ASSEMBLY FOR USE W/STATPAL
    K912627 MIDAS SYSTEM 2500, PHYSIOLOGICAL MONITORING SYSTEM
    K903965 STATPAL BLOOD GAS MONITORING SYSTEM
    K901514 XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS.
    K900246 CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512
    K901132 SARA SATCAP
    K896442 PPG BIOMEDICAL VENTILATOR MODEL IRISA
    K900700 SMU 611 UNIVERSALMONITOR
    Search all 20 clearances from Ppg Industries, Inc. →