Etiometry Platform (DAV 5.4 RAE 9.2)

by Etiometry, Inc. 510(k)

Active United States

510(k) K241479

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK241479	Date12 Feb 2025Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 9 Oct 2026.

Specification

510(k)

510(k) Number: K241479
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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