510(k) K801518
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 1980
- Date Received
- July 1, 1980
- 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