510(k) K133234
K133234 is an FDA 510(k) premarket notification submitted by Keeler Limited for the device "T-TYPE D-KAT, R-TYPE D-KAT". The FDA issued a decision of Substantially Equivalent on February 21, 2014. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. Keeler Limited has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 2014
- Date Received
- October 21, 2013
- Clearance Type
- Traditional
- 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