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FDA 510(k)

ULab Systems uDesign Software

K-Number: K200772 · 2020-06-23

ApplicantUlab Systems, Inc.
Decision Date2020-06-23
Product CodePNN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULab Systems uDesign Software is a medical device manufactured by Ulab Systems, Inc.. It received FDA 510(k) clearance on 2020-06-23 under approval number K200772. 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 ULab Systems uDesign Software?

ULab Systems uDesign Software is a medical device that received FDA 510(k) clearance on 2020-06-23. It is manufactured by Ulab Systems, Inc.. The 510(k) number is K200772.

When was ULab Systems uDesign Software approved by the FDA?

ULab Systems uDesign Software received FDA 510(k) clearance on 2020-06-23, under approval number K200772.

What company makes ULab Systems uDesign Software?

ULab Systems uDesign Software is manufactured by Ulab Systems, Inc..

What is the FDA product code for ULab Systems uDesign Software?

The FDA product code for ULab Systems uDesign Software is PNN.

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Related PubMed Literature

PMID: 42212181 Cybersecurity and Privacy Risks of Generative AI Mental-Health Chatbots: A Systematic Review and Regulatory Framework. Journal of multidisciplinary healthcare (2026) PMID: 41967377 Governing the rise of AI in healthcare: A comparative governance document and implementation implications across five jurisdictions. Social science & medicine (1982) (2026) PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41844911 Toward global standards for SaMD: introducing a proposal for Good Digital Medicine Practices (GDMP). NPJ digital medicine (2026)

Other Devices by Ulab Systems, Inc.

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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.

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