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FDA 510(k)

Sentec Digital Monitoring System (SDMS) tCOM+

K-Number: K232516 · 2024-05-17

ApplicantSentec AG
Decision Date2024-05-17
Product CodeLKD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Sentec Digital Monitoring System (SDMS) tCOM+ is a medical device manufactured by Sentec AG. It received FDA 510(k) clearance on 2024-05-17 under approval number K232516. The device is classified under product code LKD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sentec Digital Monitoring System (SDMS) tCOM+?

Sentec Digital Monitoring System (SDMS) tCOM+ is a medical device that received FDA 510(k) clearance on 2024-05-17. It is manufactured by Sentec AG. The 510(k) number is K232516.

When was Sentec Digital Monitoring System (SDMS) tCOM+ approved by the FDA?

Sentec Digital Monitoring System (SDMS) tCOM+ received FDA 510(k) clearance on 2024-05-17, under approval number K232516.

What company makes Sentec Digital Monitoring System (SDMS) tCOM+?

Sentec Digital Monitoring System (SDMS) tCOM+ is manufactured by Sentec AG.

What is the FDA product code for Sentec Digital Monitoring System (SDMS) tCOM+?

The FDA product code for Sentec Digital Monitoring System (SDMS) tCOM+ is LKD.

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Related PubMed Literature

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Other Devices by Sentec AG

K243765LuMon(TM) System

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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