FDA 510(k)

Biomonitor III, Biomonitor IIIm

K号: K201865 · 2020-12-08

决定日期2020-12-08

产品代码MXD

咨询委员会CV

决定Substantially Equivalent

器械摘要

Biomonitor III, Biomonitor IIIm is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2020-12-08 under 510(k) number K201865. The device is classified under product code MXD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Biomonitor III, Biomonitor IIIm?

Biomonitor III, Biomonitor IIIm is a medical device that received FDA 510(k) clearance on 2020-12-08. The listed applicant is Biotronik, Inc.. The 510(k) number is K201865.

When did Biomonitor III, Biomonitor IIIm receive FDA 510(k) clearance?

Biomonitor III, Biomonitor IIIm received FDA 510(k) clearance on 2020-12-08, under 510(k) number K201865.

Who is the listed applicant for Biomonitor III, Biomonitor IIIm?

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

What is the FDA product code for Biomonitor III, Biomonitor IIIm?

The FDA product code for Biomonitor III, Biomonitor IIIm is MXD.

列明Biotronik, Inc.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。

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