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BrainSee

by Darmiyan, Inc. De Novo

Active United States

De Novo DEN220066

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Direct NumberDEN220066 Date11 Jan 2024DecidedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA De Novo Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 10 Oct 2026.

Specification

De Novo

De Novo Number
FDA Product Code
QWT
Device Class
Class II
Regulation
21 CFR Part 882.1454
Advisory Committee
Neurology
FDA Decision
DENG De Novo granted