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

    8600 VITAL SIGNS MONITOR

    K Number: K042569 · Decision Sep 29, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    22
    Review Days
    8

    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
    8600 VITAL SIGNS MONITOR
    K Number
    K042569
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Criticare Systems, Inc.
    Date Received
    September 21, 2004
    Decision Date
    September 29, 2004
    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 Criticare Systems, Inc.

    K Number Device Name
    K101602 VITAL SIGNS MONITOR
    K091050 506CN PATIENT MONITOR
    K030613 VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100
    K022435 507EL VITAL SIGNS MONITOR
    K012059 8100/8500 VITAL SIGNS MONITOR
    K001020 8100 VITAL SIGNS MONITOR
    K000276 MPT 24 AND VITAL VIEW 24
    K961223 MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS
    K944860 SCHOLAR PATIENT MONITOR
    K942737 POET IQ WITH FIVE AGENT CAPABILITY
    Search all 22 clearances from Criticare Systems, Inc. →