510(k) K142179
K142179 is an FDA 510(k) premarket notification submitted by Keeler, Ltd. for the device "D-KAT Z-YPE". The FDA issued a decision of Substantially Equivalent on September 17, 2014. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. Keeler, Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 2014
- Date Received
- August 8, 2014
- Clearance Type
- Special
- 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