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FDA 510(k)

食道聽診器 9 法寸,食道聽診器 12 法寸,食道聽診器 18 法寸,食道聽診器,24 法寸

K 號:K193027 · 2020-04-02

決定日期2020-04-02
產品代碼BZT
諮詢委員會AN
決定相當於

器材摘要

Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 2020-04-02 under 510(k) number K193027. The device is classified under product code BZT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French?

Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French is a medical device that received FDA 510(k) clearance on 2020-04-02. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K193027.

When did Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French receive FDA 510(k) clearance?

Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French received FDA 510(k) clearance on 2020-04-02, under 510(k) number K193027.

Who is the listed applicant for Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French?

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

What is the FDA product code for Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French?

The FDA product code for Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French is BZT.

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其他以 Deroyal Industries, Inc. 為申請人之記錄

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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相關器械(代碼:BZT)

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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