FDA 510(k)

OCT-Camera ID 21101A3

K番号: K200516 · 2020-09-02

決定日2020-09-02

製品コードOBO

諮問委員会OP

決定Substantially Equivalent

医療機器の概要

OCT-Camera ID 21101A3 is the device name listed in this FDA 510(k) record. The listed applicant is Optomedical Technologies GmbH. It received FDA 510(k) clearance on 2020-09-02 under 510(k) number K200516. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the OCT-Camera ID 21101A3?

OCT-Camera ID 21101A3 is a medical device that received FDA 510(k) clearance on 2020-09-02. The listed applicant is Optomedical Technologies GmbH. The 510(k) number is K200516.

When did OCT-Camera ID 21101A3 receive FDA 510(k) clearance?

OCT-Camera ID 21101A3 received FDA 510(k) clearance on 2020-09-02, under 510(k) number K200516.

Who is the listed applicant for OCT-Camera ID 21101A3?

The FDA 510(k) record lists Optomedical Technologies GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OCT-Camera ID 21101A3?

The FDA product code for OCT-Camera ID 21101A3 is OBO.

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OCT-Camera ID 21101A3

医療機器の概要

よくある質問

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