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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K141936
Device Name MICROBLAB, MICROLOOP
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 Number868.1840
Classification Product Code
BZG  
Subsequent Product Code
DQA  
Date Received07/17/2014
Decision Date 12/29/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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