The following data is part of a premarket notification filed by Accutome, Inc. with the FDA for Kremer Corneometer Ultrasonic Pachometer.
| Device ID | K810660 |
| 510k Number | K810660 |
| Device Name: | KREMER CORNEOMETER ULTRASONIC PACHOMETER |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ACCUTOME, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-11 |
| Decision Date | 1981-08-21 |