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U.S. Department of Health and Human Services

Product Classification
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Device respiratory effort belt for polysomnography
Regulation Description Electroencephalograph.
Definition To assess respiratory/breathing effort by measuring the movement of chest and abdominal walls. The belts function as accessories to sleep/polysomnography (PSG) and home sleep apnea test (HSAT) systems.
Physical State Elastic band with coil, non-invasive
Technical Method Sensors (such as piezoelectric, strain-based) measure chest and abdomen expansion and contraction during respiration and generates an output signal proportional to the amount of stretch (e.g., Respiratory inductance plethysmography)
Target Area Chest, abdomen, thorax
Regulation Medical Specialty Neurology
Review Panel Anesthesiology
Product CodeSFK
Premarket Review Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 882.1400
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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