FDA 510(k)

Ventripoint 医疗系统 Plus (VMS+) 3.0

K号: K191493 · 2019-10-16

决定日期2019-10-16

产品代码LLZ

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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.

列明Ventripoint Diagnostics , Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K241222Ventripoint Medical System Plus (VMS+) 4.0 K173810Ventripoint 医疗系统 Plus（VMS+）

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