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510(k) K171996

TruWave Disposable Pressure Transducer by Edwards Lifesciences, LLC — Product Code DXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2017
Date Received
July 3, 2017
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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