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FDA 510(k) Application Details - K072979
Device Classification Name
Spirometer, Diagnostic
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
868.1840
More FDA Info for this Regulation Number
Classification Product Code
BZG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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