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510(k) K082539

MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT by Cardinal Health Germany 234 GmbH — Product Code BTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2008
Date Received
September 2, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Predicted Values, Pulmonary Function
Device Class
Class II
Regulation Number
868.1890
Review Panel
AN
Submission Type

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