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FDA 510(k)

Flex-MI

K-Number: K221958 · 2022-10-21

ApplicantEmsi, Inc.
Decision Date2022-10-21
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the Flex-MI?

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

When was Flex-MI approved by the FDA?

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

What company makes Flex-MI?

Flex-MI is manufactured by Emsi, Inc..

What is the FDA product code for Flex-MI?

The FDA product code for Flex-MI is IPF.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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