510(k) K211358
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 2022
- Date Received
- May 3, 2021
- 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