510(k) K203850
K203850 is an FDA 510(k) premarket notification submitted by Cats Tonometer, LLC for the device "CATS®-D Tonometer Prism". The FDA issued a decision of Substantially Equivalent on June 14, 2021. 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
- June 14, 2021
- Date Received
- December 31, 2020
- 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