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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device closed loop auto titration device for oral appliances
Regulation Description Auto titration device for oral appliances.
Definition A closed-loop autotitration device for intraoral appliances uses a feedback control to record changes in the patient’s respiratory status related to repositioning of the mandible during an overnight study. The data are analyzed by a Healthcare Provider and can then be used to prospectively identify patients with mild to moderate obstructive sleep apnea who may be suitable for therapy with an oral appliance and to recommend a target mandibular position.
Product CodeQCJ
Regulation Number 872.5571
Device Class 2


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