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FDA 510(k)

Patient Monitoring Cables

K-Number: K203635 · 2021-02-05

ApplicantJkh USA, LLC
Decision Date2021-02-05
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Patient Monitoring Cables is a medical device manufactured by Jkh USA, LLC. It received FDA 510(k) clearance on 2021-02-05 under approval number K203635. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Patient Monitoring Cables?

Patient Monitoring Cables is a medical device that received FDA 510(k) clearance on 2021-02-05. It is manufactured by Jkh USA, LLC. The 510(k) number is K203635.

When was Patient Monitoring Cables approved by the FDA?

Patient Monitoring Cables received FDA 510(k) clearance on 2021-02-05, under approval number K203635.

What company makes Patient Monitoring Cables?

Patient Monitoring Cables is manufactured by Jkh USA, LLC.

What is the FDA product code for Patient Monitoring Cables?

The FDA product code for Patient Monitoring Cables is DSA.

Related Clinical Trials

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Related PubMed Literature

PMID: 41970523 Large language models in healthcare quality management: a European perspective on process automation and compliance. Frontiers in digital health (2026) PMID: 41694722 Lessons from global materiovigilance systems: What India can learn? Perspectives in clinical research (2026) PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026) PMID: 41533265 Modernizing Medical Software Regulation in Bangladesh: A Roadmap for Risk-Based SaMD Oversight. Journal of medical systems (2026)

Other Devices by Jkh USA, LLC

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Related Devices (Code: DSA)

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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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