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U.S. Department of Health and Human Services

Product Classification

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Device ventilatory electrical impedance tomograph
Regulation Description Ventilatory electrical impedance tomograph.
Definition A ventilatory electrical impedance tomograph is a prescription non-invasive, non-radiological ventilatory device that provides an assessment of local impedance variation within a cross-section of a patient’s thorax.
Physical State Electrodes, belt, plethysmogram.
Technical Method Electrical impedance tomography is used to provide information of local impedance variation within a cross-section of a patient's thorax.
Target Area Thorax
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeQEB
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.1505
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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