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FDA 510(k)

NemoFAB

K-Number: K192475 · 2020-04-23

Decision Date2020-04-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NemoFAB is a medical device manufactured by Software Nemotec S.L.. It received FDA 510(k) clearance on 2020-04-23 under approval number K192475. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NemoFAB?

NemoFAB is a medical device that received FDA 510(k) clearance on 2020-04-23. It is manufactured by Software Nemotec S.L.. The 510(k) number is K192475.

When was NemoFAB approved by the FDA?

NemoFAB received FDA 510(k) clearance on 2020-04-23, under approval number K192475.

What company makes NemoFAB?

NemoFAB is manufactured by Software Nemotec S.L..

What is the FDA product code for NemoFAB?

The FDA product code for NemoFAB is LLZ.

Other Devices by Software Nemotec S.L.

Related Devices (Code: LLZ)

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.