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FDA 510(k)

Harmony

K-Number: K232555 · 2023-11-20

ApplicantTopcon Healthcare Solutions
Decision Date2023-11-20
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Harmony is a medical device manufactured by Topcon Healthcare Solutions. It received FDA 510(k) clearance on 2023-11-20 under approval number K232555. 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 2023-11-20. It is manufactured by Topcon Healthcare Solutions. The 510(k) number is K232555.

When was Harmony approved by the FDA?

Harmony received FDA 510(k) clearance on 2023-11-20, under approval number K232555.

What company makes Harmony?

Harmony is manufactured by Topcon Healthcare Solutions.

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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