510(k) K213942
K213942 is an FDA 510(k) premarket notification submitted by Nucletron B.V. for the device "Esteya". The FDA issued a decision of Substantially Equivalent on January 11, 2022. The device falls under product code JAD (System, Therapeutic, X-Ray), a Class II device regulated under 21 CFR 892.5900. Nucletron B.V. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 11, 2022
- Date Received
- December 17, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Therapeutic, X-Ray
- Device Class
- Class II
- Regulation Number
- 892.5900
- Review Panel
- RA
- Submission Type