FDA 510(k)

IS-III 活動系統

K 號：K181138 · 2018-10-03

決定日期2018-10-03

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

IS-III active System 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 2018-10-03 under 510(k) number K181138. 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?

IS-III active System is a medical device that received FDA 510(k) clearance on 2018-10-03. The listed applicant is Neobiotech Co., Ltd.. The 510(k) number is K181138.

When did IS-III active System receive FDA 510(k) clearance?

IS-III active System received FDA 510(k) clearance on 2018-10-03, under 510(k) number K181138.

Who is the listed applicant for IS-III active System?

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?

The FDA product code for IS-III active System is DZE.

其他以 Neobiotech Co., Ltd. 為申請人之記錄

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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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