FDA 510(k) Application Details - K101873

Device Classification Name Spirometer, Diagnostic

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510(K) Number K101873
Device Name Spirometer, Diagnostic
Applicant CAREFUSION GERMANY 234 GMBH
LEIBNIZSTRASSE 7
HOECHBERG 97204 DE
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Contact ELMAR NIEDERMEYER
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Regulation Number 868.1840

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Classification Product Code BZG
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Date Received 07/06/2010
Decision Date 02/10/2011
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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