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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 the device name listed in this FDA 510(k) record. The listed applicant is Topcon Healthcare Solutions. It received FDA 510(k) clearance on 2023-11-20 under 510(k) 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. The listed applicant is Topcon Healthcare Solutions. The 510(k) number is K232555.

When did Harmony receive FDA 510(k) clearance?

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

Who is the listed applicant for Harmony?

The FDA 510(k) record lists Topcon Healthcare Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Harmony?

The FDA product code for Harmony is NFJ.

Other records listing Topcon Healthcare Solutions as applicant

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.

K200954Glaucoma Module

Related Devices (Code: NFJ)

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.

K260694ZEISS CLINIC 360Carl Zeiss Meditec, AGK253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA OyK234076iCare ALTIUS CWCentervue S.P.A.K232828IMAGEnet6 Ophthalmic Data SystemTopcon CorporationK232944CALLISTO eyeCarl Zeiss Meditec, AGK231676CALLISTO eyeCarl Zeiss Meditec, AG

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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