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

    PROPAQ MONITORS, MODIFICATION

    K Number: K921497 · Decision Mar 23, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    15
    Review Days
    377

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    Basic Information

    Device Name
    PROPAQ MONITORS, MODIFICATION
    K Number
    K921497
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Protocol Systems, Inc.
    Date Received
    March 11, 1992
    Decision Date
    March 23, 1993
    Product Code
    CCK
    Advisory Committee
    Anesthesiology
    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
    CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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    Other Clearances by Protocol Systems, Inc.

    K Number Device Name
    K002725 MICROPAQ, MODELS 402 AND 404
    K972121 ACUITY CENTRAL STATION
    K951246 PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS
    K945071 PROPAQ 200 MONITOR
    K935846 MODEL ACUITY CENTRAL STATION
    K934711 PROPAQ ECG TELEMETRY OPTION
    K914838 PROPAQ 102,104,106,102EL,104EL,&106EL
    K913193 MODEL 100 CENTRAL STATION
    K910882 PROPAQ 102EL, 104EL AND 106EL
    K910772 PROPAQ 102, 104 AND 106
    Search all 15 clearances from Protocol Systems, Inc. →