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EPIC ClearView System

by Epic Research & Diagnostics, Inc. De Novo

Active United States

De Novo DEN150004

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Direct NumberDEN150004 Date15 Jul 2016DecidedStatusActive

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  • Withdrawn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
PNA
Device Class
Class I
Regulation
21 CFR Part 882.1561
Advisory Committee
Neurology
FDA Decision
DENG De Novo granted