The following data is part of a premarket notification filed by Keeler Limited with the FDA for T-type D-kat, R-type D-kat.
| Device ID | K133234 |
| 510k Number | K133234 |
| Device Name: | T-TYPE D-KAT, R-TYPE D-KAT |
| Classification | Tonometer, Manual |
| Applicant | KEELER LIMITED 456 PARKWAY Broomall, PA 19008 |
| Contact | Eugene R Vanarsdale |
| Correspondent | Eugene R Vanarsdale KEELER LIMITED 456 PARKWAY Broomall, PA 19008 |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-21 |
| Decision Date | 2014-02-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055272712200 | K133234 | 000 |
| 05055272711739 | K133234 | 000 |