FDA 510(k)

Nexcomp

K号: K181689 · 2018-11-15

决定日期2018-11-15

产品代码EBF

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决定实质等同

器械摘要

Nexcomp is the device name listed in this FDA 510(k) record. The listed applicant is Meta Biomed Co., Ltd.. It received FDA 510(k) clearance on 2018-11-15 under 510(k) number K181689. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Nexcomp?

Nexcomp is a medical device that received FDA 510(k) clearance on 2018-11-15. The listed applicant is Meta Biomed Co., Ltd.. The 510(k) number is K181689.

When did Nexcomp receive FDA 510(k) clearance?

Nexcomp received FDA 510(k) clearance on 2018-11-15, under 510(k) number K181689.

Who is the listed applicant for Nexcomp?

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

What is the FDA product code for Nexcomp?

The FDA product code for Nexcomp is EBF.

列明Meta Biomed Co., Ltd.为申报人的其他记录

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