FDA 510(k)

FlexBand Plus

K 號：K192112 · 2019-09-27

決定日期2019-09-27

產品代碼FTL

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

FlexBand Plus is the device name listed in this FDA 510(k) record. The listed applicant is International Life Sciences. It received FDA 510(k) clearance on 2019-09-27 under 510(k) number K192112. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FlexBand Plus?

FlexBand Plus is a medical device that received FDA 510(k) clearance on 2019-09-27. The listed applicant is International Life Sciences. The 510(k) number is K192112.

When did FlexBand Plus receive FDA 510(k) clearance?

FlexBand Plus received FDA 510(k) clearance on 2019-09-27, under 510(k) number K192112.

Who is the listed applicant for FlexBand Plus?

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

What is the FDA product code for FlexBand Plus?

The FDA product code for FlexBand Plus is FTL.

其他以 International Life Sciences 為申請人之記錄

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相關器械（代碼：FTL）

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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