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

    PENLON I.D.P. PRESSSURE FAILURE ALARM

    K Number: K801254 · Decision Jun 9, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    77
    Applicant Total
    10
    Review Days
    12

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    Basic Information

    Device Name
    PENLON I.D.P. PRESSSURE FAILURE ALARM
    K Number
    K801254
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2600
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Penlon, Inc.
    Date Received
    May 28, 1980
    Decision Date
    June 9, 1980
    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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