510(k) K113066
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 8, 2012
- Date Received
- October 17, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tonometer, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1930
- Review Panel
- OP
- Submission Type