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510(k) K190852

Zurich Pressure Guidewire System Model 100 by Zurich Medical, Inc. — Product Code DXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2019
Date Received
April 2, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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