510(k) K250696
K250696 is an FDA 510(k) premarket notification submitted by Manteia Technologies Co., Ltd. for the device "AccuCheck". The FDA issued a decision of Substantially Equivalent on October 24, 2025. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Manteia Technologies Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 24, 2025
- Date Received
- March 7, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accelerator, Linear, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type