Cleared Traditional

HAMILTON-C3

K161450 · Hamilton Medical AG · Anesthesiology
Apr 2017
Decision
337d
Days
Class 2
Risk

About This 510(k) Submission

K161450 is an FDA 510(k) clearance for the HAMILTON-C3, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Hamilton Medical AG (Bonaduz, CH). The FDA issued a Cleared decision on April 27, 2017, 337 days after receiving the submission on May 25, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K161450 FDA.gov
FDA Decision Cleared SESE
Date Received May 25, 2016
Decision Date April 27, 2017
Days to Decision 337 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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