Flex-MI
K号: K221958 · 2022-10-21
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申请人Emsi, Inc.
决定日期2022-10-21
产品代码IPF
咨询委员会PM
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决定实质等同
器械摘要
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.
常见问题
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.
相关器械（代码：IPF）
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官方来源
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