510(k) K093445
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 19, 2010
- Date Received
- October 21, 2009
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tonometer, Manual
- Device Class
- Class II
- Regulation Number
- 886.1930
- Review Panel
- OP
- Submission Type