Cleared Traditional

GALILEO GOLD

K040574 · Hamilton Medical, Inc. · Anesthesiology
Oct 2004
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K040574 is an FDA 510(k) clearance for the GALILEO GOLD, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Hamilton Medical, Inc. (Reno, US). The FDA issued a Cleared decision on October 27, 2004, 237 days after receiving the submission on March 4, 2004. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K040574 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2004
Decision Date October 27, 2004
Days to Decision 237 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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