BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent - Subject to Tracking Reg. 🇺🇸 United States

    THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSOR

    K Number: K960851 · Decision Sep 17, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    174
    Applicant Total
    7
    Review Days
    200

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    Basic Information

    Device Name
    THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSOR
    K Number
    K960851
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent - Subject to Tracking Reg.
    Applicant
    Pro-Tech Services, Inc.
    Date Received
    March 1, 1996
    Decision Date
    September 17, 1996
    Product Code
    BZQ
    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
    BZQ Monitor, Breathing Frequency

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    Other Clearances by Pro-Tech Services, Inc.

    K Number Device Name
    K053063 PRO-FLOW MULTIPURPOSE CANNULA
    K033402 PORTABLE SLEEP DATA RECORDER (PSDR)
    K013905 MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS
    K982293 PRESSURE TRANSDUCER AIRFLOW SENSOR
    K972515 SENSOR AMPLIFIER
    K944175 ADAM SHELL THERMOCOUPLE ASSEMBLY