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510(k) K101873

MASTERSCREEN IOS by Carefusion Germany 234 GmbH — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2011
Date Received
July 6, 2010
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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