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FDA 510(k)

Harmony

K-Number: K182376 · 2018-09-28

ApplicantTopcon Medical Systems, Inc.
Decision Date2018-09-28
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Harmony is a medical device manufactured by Topcon Medical Systems, Inc.. It received FDA 510(k) clearance on 2018-09-28 under approval number K182376. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Harmony?

Harmony is a medical device that received FDA 510(k) clearance on 2018-09-28. It is manufactured by Topcon Medical Systems, Inc.. The 510(k) number is K182376.

When was Harmony approved by the FDA?

Harmony received FDA 510(k) clearance on 2018-09-28, under approval number K182376.

What company makes Harmony?

Harmony is manufactured by Topcon Medical Systems, Inc..

What is the FDA product code for Harmony?

The FDA product code for Harmony is NFJ.

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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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