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

    CS/3 COMPACT AIRWAY MODULE, M-COVX

    K Number: K982091 · Decision Dec 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    424
    Applicant Total
    9
    Review Days
    190

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    Basic Information

    Device Name
    CS/3 COMPACT AIRWAY MODULE, M-COVX
    K Number
    K982091
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Datex-Engstrom, Inc.
    Date Received
    June 15, 1998
    Decision Date
    December 22, 1998
    Product Code
    MHX
    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
    MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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    Other Clearances by Datex-Engstrom, Inc.

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    K974792 CS/3(TM) MONITORS*
    K980384 TRIP TONOMETRY CATHETER, 18F
    K974747 CS/3 ARRHYTHMIA WORKSTATION
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