The following data is part of a premarket notification filed by Keta Corp. with the FDA for Keta Hand-held Tonometer.
| Device ID | K861027 |
| 510k Number | K861027 |
| Device Name: | KETA HAND-HELD TONOMETER |
| Classification | Prism, Gonioscopic |
| Applicant | KETA CORP. 9 CANAL ST. Danvers, MA 01923 |
| Contact | Kenneth Taylor |
| Correspondent | Kenneth Taylor KETA CORP. 9 CANAL ST. Danvers, MA 01923 |
| Product Code | HKS |
| CFR Regulation Number | 886.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-18 |
| Decision Date | 1986-05-06 |