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

    MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 )

    K Number: K063419 · Decision Dec 4, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    7
    Review Days
    21

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    Basic Information

    Device Name
    MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 )
    K Number
    K063419
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Welch Allyn Protocol, Inc.
    Date Received
    November 13, 2006
    Decision Date
    December 4, 2006
    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)

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    Other Clearances by Welch Allyn Protocol, Inc.

    K Number Device Name
    K070204 LINK TO ACUITY CLINICIAN NOTIFIER
    K033378 VITAL SIGNS MONITOR, PROPAQ LT
    K031740 VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES
    K022453 MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM
    K021681 MICROPAQ, MODELS 402, 404
    K012451 PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246