Cleared Abbreviated

GALILEO VENTILATOR

K001686 · Hamilton Medical, Inc. · Anesthesiology
Jun 2000
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K001686 is an FDA 510(k) clearance for the GALILEO VENTILATOR, 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 June 23, 2000, 36 days after receiving the submission on May 18, 2000. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K001686 FDA.gov
FDA Decision Cleared ST
Date Received May 18, 2000
Decision Date June 23, 2000
Days to Decision 36 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary —

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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