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FDA 510(k)

ProSomnus EVO 睡眠及打鼾設備，配患者監控之 ProSomnus EVO 睡眠及打鼾設備

K 號：K202529 · 2020-11-20

申請人Prosomnus Sleep Technologies, Inc.
決定日期2020-11-20
產品代碼LRK
諮詢委員會DE
決定相當於

器材摘要

ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring is the device name listed in this FDA 510(k) record. The listed applicant is Prosomnus Sleep Technologies, Inc.. It received FDA 510(k) clearance on 2020-11-20 under 510(k) number K202529. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring?

ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring is a medical device that received FDA 510(k) clearance on 2020-11-20. The listed applicant is Prosomnus Sleep Technologies, Inc.. The 510(k) number is K202529.

When did ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring receive FDA 510(k) clearance?

ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring received FDA 510(k) clearance on 2020-11-20, under 510(k) number K202529.

Who is the listed applicant for ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring?

The FDA 510(k) record lists Prosomnus Sleep Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring?

The FDA product code for ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring is LRK.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：LRK）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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