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U.S. Department of Health and Human Services

Product Classification

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Device impedance measuring device utilizing oscillation techniques
Regulation Description Pulmonary-function data calculator.
Definition To measure 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 does not have diagnostic capabilities.
Target Area Lung and airways.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodePNV
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Respiratory Devices Branch (RPDB)
Submission Type 510(k)
Regulation Number 868.1880
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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