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FDA 510(k)

IQSense 流量感應器口嘴

K 號:K150515 · 2016-01-12

決定日期2016-01-12
產品代碼BZG
諮詢委員會AN
決定相當於

器材摘要

IQSense Flow Sensor Mouthpiece is the device name listed in this FDA 510(k) record. The listed applicant is Sdi Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-01-12 under 510(k) number K150515. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IQSense Flow Sensor Mouthpiece?

IQSense Flow Sensor Mouthpiece is a medical device that received FDA 510(k) clearance on 2016-01-12. The listed applicant is Sdi Diagnostics, Inc.. The 510(k) number is K150515.

When did IQSense Flow Sensor Mouthpiece receive FDA 510(k) clearance?

IQSense Flow Sensor Mouthpiece received FDA 510(k) clearance on 2016-01-12, under 510(k) number K150515.

Who is the listed applicant for IQSense Flow Sensor Mouthpiece?

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

What is the FDA product code for IQSense Flow Sensor Mouthpiece?

The FDA product code for IQSense Flow Sensor Mouthpiece is BZG.

相關臨床試驗

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相關器械(代碼:BZG)

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。

官方來源

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