510(k) K230185
K230185 is an FDA 510(k) premarket notification submitted by Ndr Medical Technology Pte. , Ltd. for the device "ANT-X System". The FDA issued a decision of Substantially Equivalent on Jun 1, 2023. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 1, 2023
- Date Received
- Jan 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
- 510(k)
Interventional fluoroscopy