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FDA 510(k)

Ventripoint Medical System Plus (VMS+) 3.0

K-Number: K191493 · 2019-10-16

ApplicantVentripoint Diagnostics , Ltd.
Decision Date2019-10-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ventripoint Medical System Plus (VMS+) 3.0 is a medical device manufactured by Ventripoint Diagnostics , Ltd.. It received FDA 510(k) clearance on 2019-10-16 under approval number K191493. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ventripoint Medical System Plus (VMS+) 3.0?

Ventripoint Medical System Plus (VMS+) 3.0 is a medical device that received FDA 510(k) clearance on 2019-10-16. It is manufactured by Ventripoint Diagnostics , Ltd.. The 510(k) number is K191493.

When was Ventripoint Medical System Plus (VMS+) 3.0 approved by the FDA?

Ventripoint Medical System Plus (VMS+) 3.0 received FDA 510(k) clearance on 2019-10-16, under approval number K191493.

What company makes Ventripoint Medical System Plus (VMS+) 3.0?

Ventripoint Medical System Plus (VMS+) 3.0 is manufactured by Ventripoint Diagnostics , Ltd..

What is the FDA product code for Ventripoint Medical System Plus (VMS+) 3.0?

The FDA product code for Ventripoint Medical System Plus (VMS+) 3.0 is LLZ.

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Ventripoint Diagnostics , Ltd.

K173810Ventripoint Medical System Plus (VMS+) K241222Ventripoint Medical System Plus (VMS+) 4.0

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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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