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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Bacterial, Breathing-Circuit
510(k) Number K111408
Device Name MICROGARD II
Applicant
Carefusion Germany 234 GmbH
Leibnizstrasse 7
Hoechberg,  DE 97204
Applicant Contact ELMAR NIEDERMEYER
Correspondent
Carefusion Germany 234 GmbH
Leibnizstrasse 7
Hoechberg,  DE 97204
Correspondent Contact ELMAR NIEDERMEYER
Regulation Number868.5260
Classification Product Code
CAH  
Date Received05/19/2011
Decision Date 10/17/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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