FDA 510(k)

Polysmith 睡眠系統，型號 NTI7593

K 號：K161650 · 2017-01-19

決定日期2017-01-19

產品代碼OLV

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Polysmith Sleep System, Model NTI7593 is the device name listed in this FDA 510(k) record. The listed applicant is Neurotronics, Inc.. It received FDA 510(k) clearance on 2017-01-19 under 510(k) number K161650. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Polysmith Sleep System, Model NTI7593?

Polysmith Sleep System, Model NTI7593 is a medical device that received FDA 510(k) clearance on 2017-01-19. The listed applicant is Neurotronics, Inc.. The 510(k) number is K161650.

When did Polysmith Sleep System, Model NTI7593 receive FDA 510(k) clearance?

Polysmith Sleep System, Model NTI7593 received FDA 510(k) clearance on 2017-01-19, under 510(k) number K161650.

Who is the listed applicant for Polysmith Sleep System, Model NTI7593?

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

What is the FDA product code for Polysmith Sleep System, Model NTI7593?

The FDA product code for Polysmith Sleep System, Model NTI7593 is OLV.

其他以 Neurotronics, Inc. 為申請人之記錄

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相關器械（代碼：OLV）

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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