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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 K093633
Device Name INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE
Applicant
Draegerwerk AG & CO Kgaa
Moislinger Allee 53 - 55
Lübeck,  DE 23542
Applicant Contact Nataliia Semenova
Correspondent
Draeger AG & Co. KG
Moislinger Allee 53 - 55
Lübeck,  DE 23542
Correspondent Contact Dr. Bettina Moebius
Regulation Number868.5895
Classification Product Code
CBK  
Date Received11/23/2009
Decision Date 03/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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