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U.S. Department of Health and Human Services

Product Classification

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Device device indicating an exhalation event
Definition To provide visual indication of each exhalation event
Physical State The device includes a thermistor that could detect the temperature change of breath. Supplemental oxygen could also be provided.
Technical Method The device measures the time period between the current and previous exhalation and illuminates a different light during the exhalation that reflects the interval of time between breaths. This device does not calculate breath rate, e.g., breath rate per minute.
Target Area oral/nasal area, face
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodePRK
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.2375
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
Accredited Persons
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