FDA 510(k)

凱普勒II

K 號：K163265 · 2017-04-07

決定日期2017-04-07

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

Kepler II is the device name listed in this FDA 510(k) record. The listed applicant is Orbbo Surgical, LLC. It received FDA 510(k) clearance on 2017-04-07 under 510(k) number K163265. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Kepler II?

Kepler II is a medical device that received FDA 510(k) clearance on 2017-04-07. The listed applicant is Orbbo Surgical, LLC. The 510(k) number is K163265.

When did Kepler II receive FDA 510(k) clearance?

Kepler II received FDA 510(k) clearance on 2017-04-07, under 510(k) number K163265.

Who is the listed applicant for Kepler II?

The FDA 510(k) record lists Orbbo Surgical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kepler II?

The FDA product code for Kepler II is ODP.

其他以 Orbbo Surgical, LLC 為申請人之記錄

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相關器械（代碼：ODP）

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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