510(k) K232068
K232068 is an FDA 510(k) premarket notification submitted by Changzhou Sifary Medical Technology Co., Ltd. for the device "HyperLight Portable X-ray Unit". The FDA issued a decision of Substantially Equivalent on September 1, 2023. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Changzhou Sifary Medical Technology Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 1, 2023
- Date Received
- July 12, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, X-Ray, Extraoral With Timer
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type