Cleared Traditional

ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000

K111116 · Datex-Ohmeda · Anesthesiology
Sep 2011
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K111116 is an FDA 510(k) clearance for the ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Datex-Ohmeda (Madison, US). The FDA issued a Cleared decision on September 9, 2011, 141 days after receiving the submission on April 21, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K111116 FDA.gov
FDA Decision Cleared SESE
Date Received April 21, 2011
Decision Date September 09, 2011
Days to Decision 141 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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