FDA 510(k)

OCT-Camera ID 21101A3

K-Number: K200516 · 2020-09-02

Decision Date2020-09-02

Product CodeOBO

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Optomedical Technologies GmbH. The 510(k) number is K200516.

When was OCT-Camera ID 21101A3 approved by the FDA?

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

What company makes OCT-Camera ID 21101A3?

OCT-Camera ID 21101A3 is manufactured by Optomedical Technologies GmbH.

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.