FDA 510(k) Application Details - K230185

Device Classification Name

  More FDA Info for this Device
510(K) Number K230185
Device Name ANT-X System
Applicant NDR Medical Technology Pte. Ltd.
75 Ayer Rajah Crescent, #02-19
Singapore 139935 SG
Other 510(k) Applications for this Company
Contact Ng Ka Wei
Other 510(k) Applications for this Contact
Regulation Number

  More FDA Info for this Regulation Number
Classification Product Code OWB
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 01/23/2023
Decision Date 06/01/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact