The following data is part of a premarket notification filed by Eye-deas, Llc with the FDA for Eyesopen Tonometer.
| Device ID | K032769 |
| 510k Number | K032769 |
| Device Name: | EYESOPEN TONOMETER |
| Classification | Tonometer, Manual |
| Applicant | EYE-DEAS, LLC 39 SANDRINGHAM RD. Rochester, NY 14610 |
| Contact | Steven E Feldon |
| Correspondent | Erin Sparnon CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-09-08 |
| Decision Date | 2003-09-23 |
| Summary: | summary |