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510(k) K233200

XPLUS 35 Series (XPLUS 35, XPLUS 35FD) by GEMSS HEALTHCARE CO., LTD. — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2023
Date Received
September 28, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interventional Fluoroscopic X-Ray System
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Interventional fluoroscopy

Other clearances by GEMSS HEALTHCARE CO., LTD.

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