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FDA 510(k)

REMI-AI Rapid Detection Module (REMI-AI RDM)

K-Number: K240408 · 2024-10-17

ApplicantEpitel, Inc.
Decision Date2024-10-17
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

REMI-AI Rapid Detection Module (REMI-AI RDM) is the device name listed in this FDA 510(k) record. The listed applicant is Epitel, Inc.. It received FDA 510(k) clearance on 2024-10-17 under 510(k) number K240408. 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 Rapid Detection Module (REMI-AI RDM)?

REMI-AI Rapid Detection Module (REMI-AI RDM) is a medical device that received FDA 510(k) clearance on 2024-10-17. The listed applicant is Epitel, Inc.. The 510(k) number is K240408.

When did REMI-AI Rapid Detection Module (REMI-AI RDM) receive FDA 510(k) clearance?

REMI-AI Rapid Detection Module (REMI-AI RDM) received FDA 510(k) clearance on 2024-10-17, under 510(k) number K240408.

Who is the listed applicant for REMI-AI Rapid Detection Module (REMI-AI RDM)?

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 Rapid Detection Module (REMI-AI RDM)?

The FDA product code for REMI-AI Rapid Detection Module (REMI-AI RDM) 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 SystemK231779REMI AI Discrete Detection ModuleK230933REMI 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.

K260998Ceribell Neurology Review SoftwareCeribell, Inc.K252070Ceribell Infant Seizure Detection SoftwareCeribell, Inc.K252160Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development, LLCK243743autoSCORE (V 2.0.0)Holberg Eeg ASK241589Ceribell Seizure Detection SoftwareCeribell, Inc.K242446Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development Corporation

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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