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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gas-machine, anesthesia
510(k) Number K103035
Device Name SMARTPILOT VIEW MODEL MK04500
Applicant
DRAEGER MEDICAL GMBH
3135 Quarry Road
Telford,  PA  18969
Applicant Contact JOYCE KILROY
Correspondent
DRAEGER MEDICAL GMBH
3135 Quarry Road
Telford,  PA  18969
Correspondent Contact JOYCE KILROY
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received10/13/2010
Decision Date 03/28/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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