FDA 510(k)

Vario 8/18/ci

K 號：K153663 · 2016-05-18

決定日期2016-05-18

產品代碼BTA

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

Vario 8/18/ci is the device name listed in this FDA 510(k) record. The listed applicant is Medela AG. It received FDA 510(k) clearance on 2016-05-18 under 510(k) number K153663. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Vario 8/18/ci?

Vario 8/18/ci is a medical device that received FDA 510(k) clearance on 2016-05-18. The listed applicant is Medela AG. The 510(k) number is K153663.

When did Vario 8/18/ci receive FDA 510(k) clearance?

Vario 8/18/ci received FDA 510(k) clearance on 2016-05-18, under 510(k) number K153663.

Who is the listed applicant for Vario 8/18/ci?

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

What is the FDA product code for Vario 8/18/ci?

The FDA product code for Vario 8/18/ci is BTA.

其他以 Medela AG 為申請人之記錄

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相關器械（代碼：BTA）

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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