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

    MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM

    K Number: K022453 · Decision Aug 21, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    397
    Applicant Total
    7
    Review Days
    26

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    Basic Information

    Device Name
    MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM
    K Number
    K022453
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Welch Allyn Protocol, Inc.
    Date Received
    July 26, 2002
    Decision Date
    August 21, 2002
    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

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    Other Clearances by Welch Allyn Protocol, Inc.

    K Number Device Name
    K070204 LINK TO ACUITY CLINICIAN NOTIFIER
    K063419 MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 )
    K033378 VITAL SIGNS MONITOR, PROPAQ LT
    K031740 VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES
    K021681 MICROPAQ, MODELS 402, 404
    K012451 PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246