FDA 510(k) Application Details - K051572

Device Classification Name Spirometer, Diagnostic

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510(K) Number K051572
Device Name Spirometer, Diagnostic
Applicant PULMONARY DATA SERVICES, INC.
908 MAIN STREET
LOUISVILLE, CO 80027 US
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Contact DONALD HENTON
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Regulation Number 868.1840

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Classification Product Code BZG
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Date Received 06/14/2005
Decision Date 11/17/2005
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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