The following data is part of a premarket notification filed by Cats Tonometer, Llc with the FDA for Cats Tonometer Prism.
| Device ID | K173904 |
| 510k Number | K173904 |
| Device Name: | CATS Tonometer Prism |
| Classification | Tonometer, Manual |
| Applicant | CATS Tonometer, LLC 1517 N. Wilmot, Suite 143 Tucson, AZ 85712 |
| Contact | Sean J. Mccafferty |
| Correspondent | Paul Kramsky Rockin' Regulatory, Inc. 21831 Tumbleweed Circle Lake Forest, CA 92630 |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-22 |
| Decision Date | 2018-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860412001510 | K173904 | 000 |