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FDA 510(k)

trophon2

K-Number: K173865 · 2018-04-24

Decision Date2018-04-24
Product CodeOUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

trophon2 is a medical device manufactured by Nanosonics Limited. It received FDA 510(k) clearance on 2018-04-24 under approval number K173865. The device is classified under product code OUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the trophon2?

trophon2 is a medical device that received FDA 510(k) clearance on 2018-04-24. It is manufactured by Nanosonics Limited. The 510(k) number is K173865.

When was trophon2 approved by the FDA?

trophon2 received FDA 510(k) clearance on 2018-04-24, under approval number K173865.

What company makes trophon2?

trophon2 is manufactured by Nanosonics Limited.

What is the FDA product code for trophon2?

The FDA product code for trophon2 is OUJ.

Other Devices by Nanosonics Limited

Related Devices (Code: OUJ)

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.