FDA 510(k)

Flex-MI

K 號：K221958 · 2022-10-21

決定日期2022-10-21

產品代碼IPF

諮詢委員會PM

決定相當於

器材摘要

Flex-MI is the device name listed in this FDA 510(k) record. The listed applicant is Emsi, Inc.. It received FDA 510(k) clearance on 2022-10-21 under 510(k) number K221958. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Flex-MI?

Flex-MI is a medical device that received FDA 510(k) clearance on 2022-10-21. The listed applicant is Emsi, Inc.. The 510(k) number is K221958.

When did Flex-MI receive FDA 510(k) clearance?

Flex-MI received FDA 510(k) clearance on 2022-10-21, under 510(k) number K221958.

Who is the listed applicant for Flex-MI?

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

What is the FDA product code for Flex-MI?

The FDA product code for Flex-MI is IPF.

相關器械（代碼：IPF）

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