REMI Remote EEG Monitoring System— 510(k) K243185
Substantially EquivalentEpitel
FDA 510(k) clearance K243185 for REMI Remote EEG Monitoring System, Substantially Equivalent on 2025-03-21. Applicant: Epitel. Device class: 2.
Clearance details
- Applicant
- Epitel
- Product code
- Code OMC
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Recent devices under product code OMC
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