FDA 510(k)

OVENT

K 號：K160234 · 2016-03-17

決定日期2016-03-17

產品代碼LRK

諮詢委員會DE

決定相當於

器材摘要

OVENT is the device name listed in this FDA 510(k) record. The listed applicant is Oventus Manufacturing Pty, Ltd.. It received FDA 510(k) clearance on 2016-03-17 under 510(k) number K160234. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OVENT?

OVENT is a medical device that received FDA 510(k) clearance on 2016-03-17. The listed applicant is Oventus Manufacturing Pty, Ltd.. The 510(k) number is K160234.

When did OVENT receive FDA 510(k) clearance?

OVENT received FDA 510(k) clearance on 2016-03-17, under 510(k) number K160234.

Who is the listed applicant for OVENT?

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

What is the FDA product code for OVENT?

The FDA product code for OVENT is LRK.

其他以 Oventus Manufacturing Pty, 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：LRK）

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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