FDA 510(k)

LuMon(TM) System

K-Number: K243765 · 2025-08-07

Decision Date2025-08-07

Product CodeQEB

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

LuMon(TM) System is the device name listed in this FDA 510(k) record. The listed applicant is Sentec AG. It received FDA 510(k) clearance on 2025-08-07 under 510(k) number K243765. The device is classified under product code QEB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LuMon(TM) System?

LuMon(TM) System is a medical device that received FDA 510(k) clearance on 2025-08-07. The listed applicant is Sentec AG. The 510(k) number is K243765.

When did LuMon(TM) System receive FDA 510(k) clearance?

LuMon(TM) System received FDA 510(k) clearance on 2025-08-07, under 510(k) number K243765.

Who is the listed applicant for LuMon(TM) System?

The FDA 510(k) record lists Sentec AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LuMon(TM) System?

The FDA product code for LuMon(TM) System is QEB.

Other records listing Sentec AG 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.

K232516Sentec Digital Monitoring System (SDMS) tCOM+

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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.