REMI AI Discrete Detection Module— 510(k) K231779

Substantially Equivalent

Epitel, Inc.

FDA 510(k) clearance K231779 for REMI AI Discrete Detection Module, Substantially Equivalent on 2024-01-03. Applicant: Epitel, Inc.. Device class: 2.

Clearance details

Applicant: Epitel, Inc.
Product code: Code OMB
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2023-06-16
Decision date: 2024-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.