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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 K072885
Device Name CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110
Applicant
DRAEGER MEDICAL AG & CO. KG
3135 Quarry Road
Telford,  PA  18969
Applicant Contact KATHY ANDERSON
Correspondent
DRAEGER MEDICAL AG & CO. KG
3135 Quarry Road
Telford,  PA  18969
Correspondent Contact KATHY ANDERSON
Regulation Number868.5895
Classification Product Code
CBK  
Date Received10/09/2007
Decision Date 04/07/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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