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FDA 510(k)

FIRMM

K-Number: K201141 · 2020-08-26

ApplicantNous Imaging, Inc.
Decision Date2020-08-26
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FIRMM is a medical device manufactured by Nous Imaging, Inc.. It received FDA 510(k) clearance on 2020-08-26 under approval number K201141. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIRMM?

FIRMM is a medical device that received FDA 510(k) clearance on 2020-08-26. It is manufactured by Nous Imaging, Inc.. The 510(k) number is K201141.

When was FIRMM approved by the FDA?

FIRMM received FDA 510(k) clearance on 2020-08-26, under approval number K201141.

What company makes FIRMM?

FIRMM is manufactured by Nous Imaging, Inc..

What is the FDA product code for FIRMM?

The FDA product code for FIRMM is LNH.

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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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