REMI— 510(k) K203827
Substantially EquivalentEpitel, Inc.
FDA 510(k) clearance K203827 for REMI, Substantially Equivalent on 2021-03-29. Applicant: Epitel, Inc.. Device class: 2.
Clearance details
- Applicant
- Epitel, Inc.
- 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
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