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FDA 510(k) Application Details - K141936
Device Classification Name
Spirometer, Diagnostic
More FDA Info for this Device
510(K) Number
K141936
Device Name
Spirometer, Diagnostic
Applicant
CAREFUSION GERMANY 234 GMBH
LEIBNIZSTRASSE 7
HOECHBERG 97204 DE
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Contact
ELMAR NIEDERMEYER
Other 510(k) Applications for this Contact
Regulation Number
868.1840
More FDA Info for this Regulation Number
Classification Product Code
BZG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/17/2014
Decision Date
12/29/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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