510(k) K230241
K230241 is an FDA 510(k) premarket notification submitted by Sg Healthcare Co, Ltd. for the device "Jumong General". The FDA issued a decision of Substantially Equivalent on Feb 23, 2023. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Sg Healthcare Co, Ltd. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 23, 2023
- Date Received
- Jan 30, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Stationary
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type
- 510(k)