510(k) K093445
K093445 is an FDA 510(k) premarket notification submitted by Keeler, Ltd. for the device "KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT)". The FDA issued a decision of Substantially Equivalent on January 19, 2010. 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
- January 19, 2010
- Date Received
- October 21, 2009
- Clearance Type
- Abbreviated
- 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