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医疗器械 · FDA 器械监管分类(非厂家操作说明书)

Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea

Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea

Product code QNO · Class 2 · Dental

说明与适用边界

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监管定义 / Regulatory definition

A neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea consists of a removable intraoral mouthpiece that uses electrodes to deliver neuromuscular stimulation to the tongue to strengthen tongue musculature to reduce snoring and obstructive sleep apnea.

监管信息 / Regulatory information

FDA product code: QNO Device class: 2 Regulation: 872.5575 Specialty: Dental Implant flag: N Life sustaining/supporting flag: N

使用说明核对

该条目描述监管产品类别,不对应某个型号。实际操作须使用该厂家、型号和软件版本的说明书,核对预期用途、适应证、禁忌、校准、耗材兼容性、清洁灭菌、维护与报警处理。类别资料不能替代厂家使用说明。

来源、版本与许可

资料类型
FDA 器械监管分类(非厂家操作说明书)
版本
2026-10-08
获取时间
2026-10-08
许可
openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.
核对原始来源