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510(k) K090486

ASTHMA MONITOR MODEL, AM1 by Cardinal Health Germany 234 GmbH — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2009
Date Received
February 25, 2009
Clearance Type
Special
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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