FDA 510(k)

NemoFAB

K-Number: K192475 · 2020-04-23

Decision Date2020-04-23

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

NemoFAB is the device name listed in this FDA 510(k) record. The listed applicant is Software Nemotec S.L.. It received FDA 510(k) clearance on 2020-04-23 under 510(k) 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. The listed applicant is Software Nemotec S.L.. The 510(k) number is K192475.

When did NemoFAB receive FDA 510(k) clearance?

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

Who is the listed applicant for NemoFAB?

The FDA 510(k) record lists Software Nemotec S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NemoFAB?

The FDA product code for NemoFAB is LLZ.

Other records listing Software Nemotec S.L. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232698NemoScan K232549NemoCast K193003NemoCast K192571NemoScan

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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.