The following data is part of a premarket notification filed by Coburn Optical Ind., Inc. with the FDA for Retinometer.
| Device ID | K781507 |
| 510k Number | K781507 |
| Device Name: | RETINOMETER |
| Classification | Instrument, Visual Field, Laser |
| Applicant | COBURN OPTICAL IND., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HPJ |
| CFR Regulation Number | 886.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-01 |
| Decision Date | 1978-11-15 |