FDA 510(k)

LOYON

K 號：K162217 · 2017-03-23

決定日期2017-03-23

產品代碼FRO

決定相當於

器材摘要

LOYON is the device name listed in this FDA 510(k) record. The listed applicant is Oculus Innovative Sciences. It received FDA 510(k) clearance on 2017-03-23 under 510(k) number K162217. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the LOYON?

LOYON is a medical device that received FDA 510(k) clearance on 2017-03-23. The listed applicant is Oculus Innovative Sciences. The 510(k) number is K162217.

When did LOYON receive FDA 510(k) clearance?

LOYON received FDA 510(k) clearance on 2017-03-23, under 510(k) number K162217.

Who is the listed applicant for LOYON?

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

What is the FDA product code for LOYON?

The FDA product code for LOYON is FRO. This falls under the Anesthesiology category.

其他以 Oculus Innovative Sciences 為申請人之記錄

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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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