Minder® System— 510(k) K262318
Substantially EquivalentEpi-Minder Pty, Ltd.
FDA 510(k) clearance K262318 for Minder® System, Substantially Equivalent on 2026-10-29. Applicant: Epi-Minder Pty, Ltd.. Device class: 2.
Clearance details
- Applicant
- Epi-Minder Pty, Ltd.
- Product code
- Product code SEM
- Device class
- Class 2
- Regulation
- 21 CFR 882.1360
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Melbourne, AU
Recent devices under product code SEM
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