Fiber Optic Brushless Electronic Micromotor, model: iM100
FDA 510(k) K231864 · Codent Technical Industry Co., Ltd.
510(k) numberK231864
Submission
- Device name
- Fiber Optic Brushless Electronic Micromotor, model: iM100
- Applicant
- Codent Technical Industry Co., Ltd.
Kaohsiung City, TW - Received
- June 26, 2023
- Decision date
- March 11, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Fiber Optic Brushless Electronic Micromotor, model: iM100 cleared by the FDA?
Fiber Optic Brushless Electronic Micromotor, model: iM100 (K231864) received a 510(k) decision of Substantially Equivalent on March 11, 2024, 259 days after the submission was received.
What is the product code of K231864?
The FDA product code is EBW – Controller, Foot, Handpiece And Cord, a Class I (low risk) device regulated under 21 CFR 872.4200.