BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    CM7000 REMOTE INDICATOR

    K Number: K931287 · Decision Jul 1, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    77
    Applicant Total
    5
    Review Days
    111

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    Basic Information

    Device Name
    CM7000 REMOTE INDICATOR
    K Number
    K931287
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2600
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Canadian Monaghan , Ltd.
    Date Received
    March 12, 1993
    Decision Date
    July 1, 1993
    Product Code
    CAP
    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
    CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

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    Other Clearances by Canadian Monaghan , Ltd.

    K Number Device Name
    K931394 CM5000R REMOTE INDICATOR
    K925673 AIRWAY PRESSURE MONITOR CM 5000 NGAN
    K873953 CM 5000R REMOTE AIRWAY PRESSURE
    K871083 CM 5000 MONITOR AIRWAY PRESSURE