FDA 510(k)

Fenom Pro

K 號：K213611 · 2023-06-07

決定日期2023-06-07

產品代碼MXA

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決定相當於

器材摘要

Fenom Pro is the device name listed in this FDA 510(k) record. The listed applicant is Caire Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-06-07 under 510(k) number K213611. The device is classified under product code MXA. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Fenom Pro?

Fenom Pro is a medical device that received FDA 510(k) clearance on 2023-06-07. The listed applicant is Caire Diagnostics, Inc.. The 510(k) number is K213611.

When did Fenom Pro receive FDA 510(k) clearance?

Fenom Pro received FDA 510(k) clearance on 2023-06-07, under 510(k) number K213611.

Who is the listed applicant for Fenom Pro?

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

What is the FDA product code for Fenom Pro?

The FDA product code for Fenom Pro is MXA.

相關器械（代碼：MXA）

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官方來源

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