FDA 510(k)

E>アイシーエイジ

K番号: K200616 · 2020-06-11

申請者E-Swin

決定日2020-06-11

製品コードONF

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

E>EyeC is the device name listed in this FDA 510(k) record. The listed applicant is E-Swin. It received FDA 510(k) clearance on 2020-06-11 under 510(k) number K200616. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the E>EyeC?

E>EyeC is a medical device that received FDA 510(k) clearance on 2020-06-11. The listed applicant is E-Swin. The 510(k) number is K200616.

When did E>EyeC receive FDA 510(k) clearance?

E>EyeC received FDA 510(k) clearance on 2020-06-11, under 510(k) number K200616.

Who is the listed applicant for E>EyeC?

The FDA 510(k) record lists E-Swin as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E>EyeC?

The FDA product code for E>EyeC is ONF.

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医療機器の概要

よくある質問

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