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FDA 510(k)

SYPMHONY™ OCT System

K-Number: K192014 · 2020-01-24

Decision Date2020-01-24
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYPMHONY™ OCT System is a medical device manufactured by Medos International SARL. It received FDA 510(k) clearance on 2020-01-24 under approval number K192014. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYPMHONY™ OCT System?

SYPMHONY™ OCT System is a medical device that received FDA 510(k) clearance on 2020-01-24. It is manufactured by Medos International SARL. The 510(k) number is K192014.

When was SYPMHONY™ OCT System approved by the FDA?

SYPMHONY™ OCT System received FDA 510(k) clearance on 2020-01-24, under approval number K192014.

What company makes SYPMHONY™ OCT System?

SYPMHONY™ OCT System is manufactured by Medos International SARL.

What is the FDA product code for SYPMHONY™ OCT System?

The FDA product code for SYPMHONY™ OCT System is NKG.

Other Devices by Medos International SARL

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Related Devices (Code: NKG)

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.