510(k) K234037
K234037 is an FDA 510(k) premarket notification submitted by Cats Tonometer, LLC for the device "CATS-L Tonometer Prism". The FDA issued a decision of Substantially Equivalent on February 9, 2024. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. Cats Tonometer, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 2024
- Date Received
- December 21, 2023
- 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