FDA 510(k)

美林真空管吸引器

K 號：K203135 · 2021-05-04

決定日期2021-05-04

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

Medline Vacu-line Suction Aspirator is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2021-05-04 under 510(k) number K203135. 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 Medline Vacu-line Suction Aspirator?

Medline Vacu-line Suction Aspirator is a medical device that received FDA 510(k) clearance on 2021-05-04. The listed applicant is Medline Industries, Inc.. The 510(k) number is K203135.

When did Medline Vacu-line Suction Aspirator receive FDA 510(k) clearance?

Medline Vacu-line Suction Aspirator received FDA 510(k) clearance on 2021-05-04, under 510(k) number K203135.

Who is the listed applicant for Medline Vacu-line Suction Aspirator?

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

What is the FDA product code for Medline Vacu-line Suction Aspirator?

The FDA product code for Medline Vacu-line Suction Aspirator is BTA.

其他以 Medline Industries, Inc. 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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