FDA 510(k) Application Details - K071753

Device Classification Name Calculator, Predicted Values, Pulmonary Function

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510(K) Number K071753
Device Name Calculator, Predicted Values, Pulmonary Function
Applicant VIASYS HEALTHCARE GMBH
22745 SAVI RANCH PKWY.
YORBA LINDA, CA 92887 US
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Contact Yvette Lloyd
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Regulation Number 868.1890

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Classification Product Code BTY
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Date Received 06/28/2007
Decision Date 08/14/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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