Cleared Traditional

Hamilton-G5

K193228 · Hamilton Medical AG · Anesthesiology
May 2020
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K193228 is an FDA 510(k) clearance for the Hamilton-G5, 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 May 4, 2020, 164 days after receiving the submission on November 22, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K193228 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2019
Decision Date May 04, 2020
Days to Decision 164 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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