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

    BURDICK DIVISION (E-500)

    K Number: K861850 · Decision Aug 28, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    51
    Review Days
    106

    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
    BURDICK DIVISION (E-500)
    K Number
    K861850
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Mortara Instrument, Inc.
    Date Received
    May 14, 1986
    Decision Date
    August 28, 1986
    Product Code
    DPS
    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
    DPS Electrocardiograph

    Similar 510(k) Clearances

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

    MAC 7 Resting ECG Analysis System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AccurECG Analysis System (v2.0)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Withings BeamO (SCT02)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Cardiologs Holter Platform

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZBPro Diagnostic

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Masimo W1

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

    Other Clearances by Mortara Instrument, Inc.

    K Number Device Name
    K182297 Surveyor S2
    K173765 Surveyor Patient Monitor
    K161517 Mortara Surveyor Patient Monitor
    K161465 CardioConfirm
    K160685 Surveyor S4 Mobile Monitor
    K152626 H3+ Holter Recorder
    K152944 Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems
    K141020 SURVEYOR S4 MOBILE MONITOR
    K133989 AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
    K141811 MORTARA MONITORING WAVEFORM VIEWER
    Search all 51 clearances from Mortara Instrument, Inc. →