510(k) K091313
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 2010
- Date Received
- May 4, 2009
- 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