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510(k) K222216

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2022
Date Received
July 25, 2022
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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