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FDA PMA

舌下神经植入式刺激器,用于睡眠呼吸暂停

PMA编号:P130008 · 2026-08-28

决定日期2026-08-28
PMA 编号P130008
产品代码MNQ
设备分类第3类
医疗专科U
咨询委员会AN 请注意,由于您没有提供完整的医疗设备监管文本,我无法提供完整的翻译。如果您能提供完整的文本,我将很乐意为您翻译。

器械摘要

Stimulator, hypoglossal nerve, implanted, apnea is the device name listed in this FDA 510(k) record. The listed applicant is Inspire Medical Systems. It received FDA 510(k) clearance on 2026-08-28. The device is classified under product code MNQ. It was reviewed by the AN advisory panel.

常见问题

What is the Stimulator, hypoglossal nerve, implanted, apnea?

Stimulator, hypoglossal nerve, implanted, apnea is a medical device that received FDA 510(k) clearance on 2026-08-28. The listed applicant is Inspire Medical Systems.

When did Stimulator, hypoglossal nerve, implanted, apnea receive FDA 510(k) clearance?

The clearance date for Stimulator, hypoglossal nerve, implanted, apnea can be found in the official FDA records.

刺激器,植入式,舌下神经,呼吸暂停,的申请人名单是谁?

The FDA 510(k) record lists Inspire Medical Systems as the applicant. This does not by itself establish the device manufacturer.

什么是刺激器,舌下神经,植入式,呼吸暂停的FDA产品代码?

FDA产品代码为Stimulator,hypoglossal nerve,植入式,呼吸暂停的为MNQ。

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官方来源

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