Minder System

by Epi-Minder Pty, Ltd. De Novo

Active United States

De Novo DEN240062

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA De NovoDENG De Novo granted · Direct	NumberDEN240062	Date17 Apr 2025Decided	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA De Novo Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 11 Oct 2026.

Specification

De Novo

De Novo Number: DEN240062
FDA Product Code: SEM

Device Class: Class II
Regulation: 21 CFR Part 882.1360
Advisory Committee: Neurology
FDA Decision: DENG De Novo granted

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