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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 K133886
Device Name PERSEUS A500
Applicant
DRAEGER MEDICAL GMBH
6 TECH DRIVE
ANDOVER,  MA  01810
Applicant Contact BETH ZIS
Correspondent
DRAEGER MEDICAL GMBH
6 TECH DRIVE
ANDOVER,  MA  01810
Correspondent Contact BETH ZIS
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received12/20/2013
Decision Date 06/20/2014
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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