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

    GOLDWAY PATIENT MONITOR, MODEL # UT4000F

    K Number: K021154 · Decision Apr 11, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    2
    Review Days
    366

    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
    GOLDWAY PATIENT MONITOR, MODEL # UT4000F
    K Number
    K021154
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Goldway Us, Inc.
    Date Received
    April 10, 2002
    Decision Date
    April 11, 2003
    Product Code
    MWI
    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
    MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

    Similar 510(k) Clearances

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

    Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    c-med0 alpha

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WAVE Clinical Platform (2.0.000)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WARD-CSS (v1.2.x)

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

    Other Clearances by Goldway Us, Inc.

    K Number Device Name
    K021153 GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000