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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 K093632
Device Name INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE
Applicant
DRAGER MEDICAL AG & CO. KGAA
3135 Quarry Road
Telford,  PA  18969
Applicant Contact JOYCE KILROY
Correspondent
DRAGER MEDICAL AG & CO. KGAA
3135 Quarry Road
Telford,  PA  18969
Correspondent Contact JOYCE KILROY
Regulation Number868.5895
Classification Product Code
CBK  
Date Received11/23/2009
Decision Date 04/05/2010
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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