Encora X1— 510(k) K251517

Substantially Equivalent

Encora, Inc.

FDA 510(k) clearance K251517 for Encora X1, Substantially Equivalent on 2026-02-05. Applicant: Encora, Inc.. Device class: 2.

Clearance details

Applicant: Encora, Inc.
Product code: Code QBC
Device class: Class 2
Regulation: 21 CFR 882.5897
Advisory panel: Neurology
Date received: 2025-05-16
Decision date: 2026-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.