Cleared Traditional

Care Orchestrator Essence

K183226 · Respironics, Inc. · Anesthesiology
Oct 2019
Decision
332d
Days
Class 2
Risk

About This 510(k) Submission

K183226 is an FDA 510(k) clearance for the Care Orchestrator Essence, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on October 18, 2019, 332 days after receiving the submission on November 20, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K183226 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 2018
Decision Date October 18, 2019
Days to Decision 332 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZD — Ventilator, Non-continuous (respirator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905

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