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FDA 510(k)

Canon OCT-A1

K-Number: K182942 · 2019-07-24

ApplicantCanon, Inc.
Decision Date2019-07-24
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Canon OCT-A1 is the device name listed in this FDA 510(k) record. The listed applicant is Canon, Inc.. It received FDA 510(k) clearance on 2019-07-24 under 510(k) number K182942. 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 Canon OCT-A1?

Canon OCT-A1 is a medical device that received FDA 510(k) clearance on 2019-07-24. The listed applicant is Canon, Inc.. The 510(k) number is K182942.

When did Canon OCT-A1 receive FDA 510(k) clearance?

Canon OCT-A1 received FDA 510(k) clearance on 2019-07-24, under 510(k) number K182942.

Who is the listed applicant for Canon OCT-A1?

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

What is the FDA product code for Canon OCT-A1?

The FDA product code for Canon OCT-A1 is OBO.

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Official Source

View on FDA Database →

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

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