FAQ (FAQ 401); FAQ (FAQ 402)— 510(k) K261625

Substantially Equivalent

Foreo, Inc.

FDA 510(k) clearance K261625 for FAQ (FAQ 401); FAQ (FAQ 402), Substantially Equivalent on 2026-10-26. Applicant: Foreo, Inc.. Device class: 2.

Clearance details

Device name as filed
FAQ (FAQ 401);FAQ (FAQ 402)
Applicant
Foreo, Inc.
Product code
Product code NFO
Device class
Class 2
Regulation
21 CFR 882.5890
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Las Vegas, NV, US
Download summary PDFView on FDA.gov ↗

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