Cleared Traditional

HAMILTON-T1, HAMILTON-C1

K181216 · Hamilton Medical AG · Anesthesiology
Aug 2019
Decision
452d
Days
Class 2
Risk

About This 510(k) Submission

K181216 is an FDA 510(k) clearance for the HAMILTON-T1, HAMILTON-C1, 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 August 2, 2019, 452 days after receiving the submission on May 7, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K181216 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2018
Decision Date August 02, 2019
Days to Decision 452 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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