The following data is part of a premarket notification filed by Keeler Instruments Inc. with the FDA for Keeler Tonocare Tonometer.
| Device ID | K181143 |
| 510k Number | K181143 |
| Device Name: | Keeler TonoCare Tonometer |
| Classification | Tonometer, Ac-powered |
| Applicant | Keeler Instruments Inc. 3222 Phoenixville Pike Malvern, PA 19355 |
| Contact | Eugene Vanarsdale |
| Correspondent | Eugene Vanarsdale Keeler Instruments Inc. 3222 Phoenixville Pike Malvern, PA 19355 |
| Product Code | HKX |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-01 |
| Decision Date | 2019-02-08 |
| Summary: | summary |