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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K080181
Device Name MODIFICATION TO GALILEO GOLD
Applicant
HAMILTON MEDICAL AG
VIA CRUSCH 8
BONADUZ,  CH CH-7402
Applicant Contact JOERG SCHNEIDER
Correspondent
HAMILTON MEDICAL AG
VIA CRUSCH 8
BONADUZ,  CH CH-7402
Correspondent Contact JOERG SCHNEIDER
Regulation Number868.5895
Classification Product Code
CBK  
Date Received01/24/2008
Decision Date 06/24/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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