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

    PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246

    K Number: K012451 · Decision Aug 20, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    338
    Applicant Total
    7
    Review Days
    19

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    Basic Information

    Device Name
    PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246
    K Number
    K012451
    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
    August 1, 2001
    Decision Date
    August 20, 2001
    Product Code
    DRT
    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
    DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

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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
    K022453 MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM
    K021681 MICROPAQ, MODELS 402, 404