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510(k) K141495

TRUWAVE DISPOSABLE PRESSURE TRANSDUCER by Edwards Lifesciences, LLC — Product Code DXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2014
Date Received
June 6, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Pressure, Catheter Tip
Device Class
Class II
Regulation Number
870.2870
Review Panel
CV
Submission Type

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