510(k) K112605
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 19, 2012
- Date Received
- September 7, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Counter, Differential Cell
- Device Class
- Class II
- Regulation Number
- 864.5220
- Review Panel
- HE
- Submission Type