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510(k) K212003

ESSENZ Patient Monitor by Livanova Deutschland, GmbH — Product Code DXJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2021
Date Received
June 28, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Display, Cathode-Ray Tube, Medical
Device Class
Class II
Regulation Number
870.2450
Review Panel
CV
Submission Type

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