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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 K060705
Device Name CARINA HOME
Applicant
Draeger Medical B.V.
3135 Quarry Rd.
Telford,  PA  18969
Applicant Contact MONICA FERRANTE
Correspondent
Draeger Medical B.V.
3135 Quarry Rd.
Telford,  PA  18969
Correspondent Contact MONICA FERRANTE
Regulation Number868.5895
Classification Product Code
CBK  
Date Received03/16/2006
Decision Date 06/14/2006
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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