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510(k) K181891

Portable X-ray System (Model: MiniX-V, Mini X-S) by Digimed Co., Ltd. — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2018
Date Received
July 13, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Extraoral With Timer
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

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