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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 the device name listed in this FDA 510(k) record. The listed applicant is Ventripoint Diagnostics , Ltd.. It received FDA 510(k) clearance on 2019-10-16 under 510(k) 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. The listed applicant is Ventripoint Diagnostics , Ltd.. The 510(k) number is K191493.

When did Ventripoint Medical System Plus (VMS+) 3.0 receive FDA 510(k) clearance?

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

Who is the listed applicant for Ventripoint Medical System Plus (VMS+) 3.0?

The FDA 510(k) record lists Ventripoint Diagnostics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Ventripoint Diagnostics , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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