Harmony Referral System
K-Number: K210396 · 2021-09-13
ApplicantTopcon Healthcare Solutions EMEA Oy
Decision Date2021-09-13
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Harmony Referral System is a medical device manufactured by Topcon Healthcare Solutions EMEA Oy. It received FDA 510(k) clearance on 2021-09-13 under approval number K210396. 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 Referral System?
Harmony Referral System is a medical device that received FDA 510(k) clearance on 2021-09-13. It is manufactured by Topcon Healthcare Solutions EMEA Oy. The 510(k) number is K210396.
When was Harmony Referral System approved by the FDA?
Harmony Referral System received FDA 510(k) clearance on 2021-09-13, under approval number K210396.
What company makes Harmony Referral System?
Harmony Referral System is manufactured by Topcon Healthcare Solutions EMEA Oy.
What is the FDA product code for Harmony Referral System?
The FDA product code for Harmony Referral System 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.