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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
Recalls CDRH Recalls
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