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

    RESPIRATOR DISCONNECT ALARM

    K Number: K792515 · Decision Jan 9, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    77
    Applicant Total
    5
    Review Days
    35

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    Basic Information

    Device Name
    RESPIRATOR DISCONNECT ALARM
    K Number
    K792515
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2600
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Intersect Medical Products, Inc.
    Date Received
    December 5, 1979
    Decision Date
    January 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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    Other Clearances by Intersect Medical Products, Inc.

    K Number Device Name
    K945543 GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONE
    K792516 RESPIRATOR DISCONNECT ALARM CR 201
    K791527 RESPIRATOR DISCONNECT ALARM CR201
    K791561 RESPIRATOR DISCONNECT ALARM VA-100