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FDA 510(k)

Thora-3Di,型號 T-01

K 號:K151940 · 2016-03-10

決定日期2016-03-10
產品代碼BZQ
諮詢委員會AN
決定相當於

器材摘要

Thora-3Di, Model T-01 is the device name listed in this FDA 510(k) record. The listed applicant is Pneumacare Limited. It received FDA 510(k) clearance on 2016-03-10 under 510(k) number K151940. 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 Thora-3Di, Model T-01?

Thora-3Di, Model T-01 is a medical device that received FDA 510(k) clearance on 2016-03-10. The listed applicant is Pneumacare Limited. The 510(k) number is K151940.

When did Thora-3Di, Model T-01 receive FDA 510(k) clearance?

Thora-3Di, Model T-01 received FDA 510(k) clearance on 2016-03-10, under 510(k) number K151940.

Who is the listed applicant for Thora-3Di, Model T-01?

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

What is the FDA product code for Thora-3Di, Model T-01?

The FDA product code for Thora-3Di, Model T-01 is BZQ.

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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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