FDA 510(k)

光子學專業版

K 號：K160880 · 2016-09-23

決定日期2016-09-23

產品代碼OLI

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

Photonica Professional is the device name listed in this FDA 510(k) record. The listed applicant is Ward Photonics, LLC. It received FDA 510(k) clearance on 2016-09-23 under 510(k) number K160880. The device is classified under product code OLI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Photonica Professional?

Photonica Professional is a medical device that received FDA 510(k) clearance on 2016-09-23. The listed applicant is Ward Photonics, LLC. The 510(k) number is K160880.

When did Photonica Professional receive FDA 510(k) clearance?

Photonica Professional received FDA 510(k) clearance on 2016-09-23, under 510(k) number K160880.

Who is the listed applicant for Photonica Professional?

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

What is the FDA product code for Photonica Professional?

The FDA product code for Photonica Professional is OLI.

其他以 Ward Photonics, LLC 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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