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Impedance Measuring Device Utilizing Oscillation Techniques

Page Type
Product Code
Definition
This device measures respiratory impedance.
Physical State
Device could include a loudspeaker or other means to generate pressure oscillatory signals. The system could also include a bias flow.
Technical Method
Device applies pressure oscillatory signals at the patient’s mouth during spontaneous breathing and measures the response of the respiratory system in terms of impedance, which is the complex ratio between the recorded mouth pressure and the airflow. The frequency of the test signal varies. The device is not intended to be used as a standalone diagnostic device.
Target Area
Lung and airways.
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.1840
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 868.1840 Diagnostic spirometer

§ 868.1840 Diagnostic spirometer.

(a) Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.

(b) Classification. Class II (performance standards).

Impedance Measuring Device Utilizing Oscillation Techniques

Page Type
Product Code
Definition
This device measures respiratory impedance.
Physical State
Device could include a loudspeaker or other means to generate pressure oscillatory signals. The system could also include a bias flow.
Technical Method
Device applies pressure oscillatory signals at the patient’s mouth during spontaneous breathing and measures the response of the respiratory system in terms of impedance, which is the complex ratio between the recorded mouth pressure and the airflow. The frequency of the test signal varies. The device is not intended to be used as a standalone diagnostic device.
Target Area
Lung and airways.
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.1840
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 868.1840 Diagnostic spirometer

§ 868.1840 Diagnostic spirometer.

(a) Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.

(b) Classification. Class II (performance standards).