510(k) K212787
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 8, 2021
- Date Received
- September 1, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Electroconductive
- Device Class
- Class II
- Regulation Number
- 882.1275
- Review Panel
- NE
- Submission Type