510(k) K213405
K213405 is an FDA 510(k) premarket notification submitted by Hdt Co., Ltd. for the device "MINE ALNU (Model: Mine 2.1)". The FDA issued a decision of Substantially Equivalent on Jul 10, 2022. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 10, 2022
- Date Received
- Oct 19, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Mobile
- Device Class
- Class II
- Regulation Number
- 892.1720
- Review Panel
- RA
- Submission Type
- 510(k)