510(k) K213282
K213282 is an FDA 510(k) premarket notification submitted by Energy Resources International Co., Ltd. Hsinchu Branch for the device "ERI Handheld Dental X-ray System (Model AG100)". The FDA issued a decision of Substantially Equivalent on Apr 4, 2022. 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
- Apr 4, 2022
- Date Received
- Oct 1, 2021
- 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
- 510(k)