FDA 510(k)

IS-III 活動系統_S-窄型

K 號：K190849 · 2019-08-14

決定日期2019-08-14

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

IS-III active System_S-narrow Type is the device name listed in this FDA 510(k) record. The listed applicant is Neobiotech Co., Ltd.. It received FDA 510(k) clearance on 2019-08-14 under 510(k) number K190849. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IS-III active System_S-narrow Type?

IS-III active System_S-narrow Type is a medical device that received FDA 510(k) clearance on 2019-08-14. The listed applicant is Neobiotech Co., Ltd.. The 510(k) number is K190849.

When did IS-III active System_S-narrow Type receive FDA 510(k) clearance?

IS-III active System_S-narrow Type received FDA 510(k) clearance on 2019-08-14, under 510(k) number K190849.

Who is the listed applicant for IS-III active System_S-narrow Type?

The FDA 510(k) record lists Neobiotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IS-III active System_S-narrow Type?

The FDA product code for IS-III active System_S-narrow Type is DZE.

其他以 Neobiotech Co., Ltd. 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：DZE）

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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