FDA 510(k)

Vivo 45 LS

K号: K232365 · 2025-12-19

申请人Oconnell Regulatory Consultants, Inc.

决定日期2025-12-19

产品代码CBK

咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。

决定实质等同

器械摘要

Vivo 45 LS is the device name listed in this FDA 510(k) record. The listed applicant is Oconnell Regulatory Consultants, Inc.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K232365. 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 Vivo 45 LS?

Vivo 45 LS is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Oconnell Regulatory Consultants, Inc.. The 510(k) number is K232365.

When did Vivo 45 LS receive FDA 510(k) clearance?

Vivo 45 LS received FDA 510(k) clearance on 2025-12-19, under 510(k) number K232365.

Who is the listed applicant for Vivo 45 LS?

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

What is the FDA product code for Vivo 45 LS?

The FDA product code for Vivo 45 LS is CBK.

相关器械（代码：CBK）

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