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510(k) K172969

Essence 55S Large Monitor System by Shenyang Torch-Bigtide Digital Technology Co., Ltd. — Product Code DXJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2018
Date Received
September 26, 2017
Clearance Type
Traditional
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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