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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 the device name listed in this FDA 510(k) record. The listed applicant is Epitel, Inc.. It received FDA 510(k) clearance on 2024-01-03 under 510(k) 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. The listed applicant is Epitel, Inc.. The 510(k) number is K231779.

When did REMI AI Discrete Detection Module receive FDA 510(k) clearance?

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

Who is the listed applicant for REMI AI Discrete Detection Module?

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

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

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

Other records listing Epitel, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243185REMI Remote EEG Monitoring SystemK240408REMI-AI Rapid Detection Module (REMI-AI RDM)K230933REMI Remote EEG Monitoring SystemK203827REMI

Related Devices (Code: OMB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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