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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 K083050
Device Name EVITE XL
Applicant
Draeger Medical AG & Co. KG
3135 Quarry Rd.
Telford,  PA  18969
Applicant Contact JOYCE KILROY
Correspondent
Draeger Medical AG & Co. KG
3135 Quarry Rd.
Telford,  PA  18969
Correspondent Contact JOYCE KILROY
Regulation Number868.5895
Classification Product Code
CBK  
Date Received10/14/2008
Decision Date 12/29/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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