FDA 510(k) Application Details - K072979

Device Classification Name Spirometer, Diagnostic

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510(K) Number K072979
Device Name Spirometer, Diagnostic
Applicant MIR MEDICAL INTL. RESEARCH SRL
VIA DEL MAGGIOLINO 125
ROMA 00155 IT
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Contact SIMON FOWLER
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Regulation Number 868.1840

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Classification Product Code BZG
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Date Received 10/22/2007
Decision Date 12/26/2007
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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