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510(k) K093174

SPIROPALM by Cosmed Srl — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2010
Date Received
October 8, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Diagnostic
Device Class
Class II
Regulation Number
868.1840
Review Panel
AN
Submission Type

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