Earflo (EF001)— 510(k) K252751

Substantially Equivalent

Earflo, Inc.

FDA 510(k) clearance K252751 for Earflo (EF001), Substantially Equivalent on 2026-02-10. Applicant: Earflo, Inc.. Device class: Unclassified.

Clearance details

Applicant: Earflo, Inc.
Product code: Code MJV
Device class: Unclassified
Advisory panel: Unknown
Date received: 2025-08-29
Decision date: 2026-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Carlos, CA, 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.