510(k) K231864

Fiber Optic Brushless Electronic Micromotor, model: iM100 by Codent Technical Industry Co., Ltd. — Product Code EBW

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