FDA 510(k) Application Details - K023120

Device Classification Name Calculator, Pulmonary Function Data

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510(K) Number K023120
Device Name Calculator, Pulmonary Function Data
Applicant ERICH JAEGER GMBH
22705 SAVI RANCH PKWY.
YORBA LINDA, CA 92887-4645 US
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Contact EARL DRAPER
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Regulation Number 868.1880

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Classification Product Code BZC
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Date Received 09/19/2002
Decision Date 11/12/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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