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FDA 510(k)

OCT-Camera ID 21101A3

K-Number: K200516 · 2020-09-02

ApplicantOptomedical Technologies GmbH
Decision Date2020-09-02
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

Related Devices (Code: OBO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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