510(k) K241963
K241963 is an FDA 510(k) premarket notification submitted by Picopack Co., Ltd. for the device "WERAY". The FDA issued a decision of Substantially Equivalent on July 30, 2024. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 2024
- Date Received
- July 3, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Unit, X-Ray, Extraoral With Timer
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type