510(k) K173904
K173904 is an FDA 510(k) premarket notification submitted by Cats Tonometer, LLC for the device "CATS Tonometer Prism". The FDA issued a decision of Substantially Equivalent on March 9, 2018. 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
- March 9, 2018
- Date Received
- December 22, 2017
- 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