Cleared Traditional

Trilogy Evo

K181166 · Respironics, Inc. · Anesthesiology
Jul 2019
Decision
442d
Days
Class 2
Risk

About This 510(k) Submission

K181166 is an FDA 510(k) clearance for the Trilogy Evo, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on July 18, 2019, 442 days after receiving the submission on May 2, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K181166 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2018
Decision Date July 18, 2019
Days to Decision 442 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBK — Ventilator, Continuous, Facility Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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