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

    VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES

    K Number: K031740 · Decision Aug 26, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    7
    Review Days
    83

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    Basic Information

    Device Name
    VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES
    K Number
    K031740
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Welch Allyn Protocol, Inc.
    Date Received
    June 4, 2003
    Decision Date
    August 26, 2003
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DQA Oximeter

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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
    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