FDA 510(k)

VM-2000

K号: K240807 · 2024-08-13

决定日期2024-08-13

产品代码CBK

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决定实质等同

器械摘要

VM-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Ventis Medical, Inc.. It received FDA 510(k) clearance on 2024-08-13 under 510(k) number K240807. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VM-2000?

VM-2000 is a medical device that received FDA 510(k) clearance on 2024-08-13. The listed applicant is Ventis Medical, Inc.. The 510(k) number is K240807.

When did VM-2000 receive FDA 510(k) clearance?

VM-2000 received FDA 510(k) clearance on 2024-08-13, under 510(k) number K240807.

Who is the listed applicant for VM-2000?

The FDA 510(k) record lists Ventis Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VM-2000?

The FDA product code for VM-2000 is CBK.

相关器械（代码：CBK）

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