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FDA 510(k)

NemoCast

K-Number: K232549 · 2023-11-21

Decision Date2023-11-21
Product CodePNN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NemoCast 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 2023-11-21 under 510(k) number K232549. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NemoCast?

NemoCast is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Software Nemotec S.L.. The 510(k) number is K232549.

When did NemoCast receive FDA 510(k) clearance?

NemoCast received FDA 510(k) clearance on 2023-11-21, under 510(k) number K232549.

Who is the listed applicant for NemoCast?

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 NemoCast?

The FDA product code for NemoCast is PNN.

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.

Related Devices (Code: PNN)

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.

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.