FDA 510(k)

AmplifEYE

K 號：K160846 · 2016-07-14

決定日期2016-07-14

產品代碼FED

諮詢委員會GU

決定相當於

器材摘要

AmplifEYE is the device name listed in this FDA 510(k) record. The listed applicant is Medivators, Inc.. It received FDA 510(k) clearance on 2016-07-14 under 510(k) number K160846. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AmplifEYE?

AmplifEYE is a medical device that received FDA 510(k) clearance on 2016-07-14. The listed applicant is Medivators, Inc.. The 510(k) number is K160846.

When did AmplifEYE receive FDA 510(k) clearance?

AmplifEYE received FDA 510(k) clearance on 2016-07-14, under 510(k) number K160846.

Who is the listed applicant for AmplifEYE?

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

What is the FDA product code for AmplifEYE?

The FDA product code for AmplifEYE is FED.

其他以 Medivators, Inc. 為申請人之記錄

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