Etiometry Platform— 510(k) K254066

Substantially Equivalent

Etiometry, Inc.

FDA 510(k) clearance K254066 for Etiometry Platform, Substantially Equivalent on 2026-04-03. Applicant: Etiometry, Inc..

Clearance details

Applicant: Etiometry, Inc.
Product code: Code PPW
Advisory panel: Cardiovascular
Date received: 2025-12-18
Decision date: 2026-04-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Dedham, MA, US

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