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510(k) K230185

ANT-X System by Ndr Medical Technology Pte. , Ltd. — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2023
Date Received
January 23, 2023
Clearance Type
Abbreviated
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

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