FDA 510(k)

ExSpiron 1Xi

K 號：K162131 · 2017-05-09

決定日期2017-05-09

產品代碼BZK

諮詢委員會AN

決定相當於

器材摘要

ExSpiron 1Xi is the device name listed in this FDA 510(k) record. The listed applicant is Respiratory Motion, Inc.. It received FDA 510(k) clearance on 2017-05-09 under 510(k) number K162131. The device is classified under product code BZK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ExSpiron 1Xi?

ExSpiron 1Xi is a medical device that received FDA 510(k) clearance on 2017-05-09. The listed applicant is Respiratory Motion, Inc.. The 510(k) number is K162131.

When did ExSpiron 1Xi receive FDA 510(k) clearance?

ExSpiron 1Xi received FDA 510(k) clearance on 2017-05-09, under 510(k) number K162131.

Who is the listed applicant for ExSpiron 1Xi?

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

What is the FDA product code for ExSpiron 1Xi?

The FDA product code for ExSpiron 1Xi is BZK.

其他以 Respiratory Motion, Inc. 為申請人之記錄

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K173181ExSpiron 1Xi

相關器械（代碼：BZK）

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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