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

    QUEST EXERCISE STRESS SYSTEM

    K Number: K952417 · Decision May 22, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    397
    Applicant Total
    6
    Review Days
    365

    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
    QUEST EXERCISE STRESS SYSTEM
    K Number
    K952417
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Burdick, Inc.
    Date Received
    May 23, 1995
    Decision Date
    May 22, 1996
    Product Code
    DSI
    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
    DSI Detector And Alarm, Arrhythmia

    Similar 510(k) Clearances

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

    BodyGuardian Remote Monitoring System (BGRMS v3.0)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Zio AT® device (A100A1001)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SmartCardia 7L Platform

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Unified Arrhythmia Diagnostic System PocketECG IV

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

    Other Clearances by Burdick, Inc.

    K Number Device Name
    K954267 BURDICK 200 PULSE OXIMETER
    K946281 ECLIPSE 4 ELECTROCARDIOGRAPH
    K945985 PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400
    K943959 ECLIPSE 4 ELECTROCARDIOGRAPH
    K942438 ALTAIR 6100 CASSETTE RECORDER