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Etiometry Platform

by Etiometry, Inc. 510(k)

Active United States

510(k) K254066

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK254066 Date3 Apr 2026ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 11 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
PPW
Device Class
Class II
Regulation
21 CFR Part 870.2200
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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