510(k) K111710
K111710 is an FDA 510(k) premarket notification submitted by Canon Inc. -Medical Equipment Group for the device "FULL AUTO TONOMETER MODEL TX-20". The FDA issued a decision of Substantially Equivalent on September 20, 2011. The device falls under product code HKX (Tonometer, Ac-Powered), a Class II device regulated under 21 CFR 886.1930. Canon Inc. -Medical Equipment Group has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 2011
- Date Received
- June 20, 2011
- Clearance Type
- Special
- 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