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FDA 510(k)

Unite Connect for Clinical Systems

K-Number: K180566 · 2018-04-03

ApplicantAscom Sweden AB
Decision Date2018-04-03
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Unite Connect for Clinical Systems is a medical device manufactured by Ascom Sweden AB. It received FDA 510(k) clearance on 2018-04-03 under approval number K180566. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Unite Connect for Clinical Systems?

Unite Connect for Clinical Systems is a medical device that received FDA 510(k) clearance on 2018-04-03. It is manufactured by Ascom Sweden AB. The 510(k) number is K180566.

When was Unite Connect for Clinical Systems approved by the FDA?

Unite Connect for Clinical Systems received FDA 510(k) clearance on 2018-04-03, under approval number K180566.

What company makes Unite Connect for Clinical Systems?

Unite Connect for Clinical Systems is manufactured by Ascom Sweden AB.

What is the FDA product code for Unite Connect for Clinical Systems?

The FDA product code for Unite Connect for Clinical Systems is MSX.

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Related PubMed Literature

PMID: 42207283 [Legal responsibility in AI-assisted radiological reporting]. Radiologie (Heidelberg, Germany) (2026) PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41844911 Toward global standards for SaMD: introducing a proposal for Good Digital Medicine Practices (GDMP). NPJ digital medicine (2026)

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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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