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FDA 510(k)

SYMPHONY™ OCT System

K-Number: K181949 · 2018-10-04

Decision Date2018-10-04
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYMPHONY™ OCT System is a medical device manufactured by Medos International SARL. It received FDA 510(k) clearance on 2018-10-04 under approval number K181949. 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 SYMPHONY™ OCT System?

SYMPHONY™ OCT System is a medical device that received FDA 510(k) clearance on 2018-10-04. It is manufactured by Medos International SARL. The 510(k) number is K181949.

When was SYMPHONY™ OCT System approved by the FDA?

SYMPHONY™ OCT System received FDA 510(k) clearance on 2018-10-04, under approval number K181949.

What company makes SYMPHONY™ OCT System?

SYMPHONY™ OCT System is manufactured by Medos International SARL.

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

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

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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.