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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 the device name listed in this FDA 510(k) record. The listed applicant is Topcon Medical Systems, Inc.. It received FDA 510(k) clearance on 2018-09-28 under 510(k) 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. The listed applicant is Topcon Medical Systems, Inc.. The 510(k) number is K182376.

When did Harmony receive FDA 510(k) clearance?

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

Who is the listed applicant for Harmony?

The FDA 510(k) record lists Topcon Medical Systems, Inc. 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.

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, AGK232555HarmonyTopcon Healthcare Solutions

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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