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FDA 510(k)

REMI AI Discrete Detection Module

K-Number: K231779 · 2024-01-03

ApplicantEpitel, Inc.
Decision Date2024-01-03
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

REMI AI Discrete Detection Module is a medical device manufactured by Epitel, Inc.. It received FDA 510(k) clearance on 2024-01-03 under approval number K231779. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REMI AI Discrete Detection Module?

REMI AI Discrete Detection Module is a medical device that received FDA 510(k) clearance on 2024-01-03. It is manufactured by Epitel, Inc.. The 510(k) number is K231779.

When was REMI AI Discrete Detection Module approved by the FDA?

REMI AI Discrete Detection Module received FDA 510(k) clearance on 2024-01-03, under approval number K231779.

What company makes REMI AI Discrete Detection Module?

REMI AI Discrete Detection Module is manufactured by Epitel, Inc..

What is the FDA product code for REMI AI Discrete Detection Module?

The FDA product code for REMI AI Discrete Detection Module is OMB.

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Official Source

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