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FDA 510(k)

林士宏呼吸監測設備(LRMD)

K 號:K190734 · 2020-01-30

決定日期2020-01-30
產品代碼BZQ
諮詢委員會AN
決定相當於

器材摘要

Linshom Respiratory Monitoring Device (LRMD) is the device name listed in this FDA 510(k) record. The listed applicant is Linshom Management, LLC. It received FDA 510(k) clearance on 2020-01-30 under 510(k) number K190734. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Linshom Respiratory Monitoring Device (LRMD)?

Linshom Respiratory Monitoring Device (LRMD) is a medical device that received FDA 510(k) clearance on 2020-01-30. The listed applicant is Linshom Management, LLC. The 510(k) number is K190734.

When did Linshom Respiratory Monitoring Device (LRMD) receive FDA 510(k) clearance?

Linshom Respiratory Monitoring Device (LRMD) received FDA 510(k) clearance on 2020-01-30, under 510(k) number K190734.

Who is the listed applicant for Linshom Respiratory Monitoring Device (LRMD)?

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

What is the FDA product code for Linshom Respiratory Monitoring Device (LRMD)?

The FDA product code for Linshom Respiratory Monitoring Device (LRMD) is BZQ.

相關臨床試驗

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相關器械(代碼:BZQ)

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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