510(k) K231864
K231864 is an FDA 510(k) premarket notification submitted by Codent Technical Industry Co., Ltd. for the device "Fiber Optic Brushless Electronic Micromotor, model: iM100". The FDA issued a decision of Substantially Equivalent on March 11, 2024. The device falls under product code EBW (Controller, Foot, Handpiece And Cord), a Class I device regulated under 21 CFR 872.4200. Codent Technical Industry Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 2024
- Date Received
- June 26, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Controller, Foot, Handpiece And Cord
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type