The following data is part of a premarket notification filed by American Optical Corp. with the FDA for Ao Non-contact Ii Tonometer.
| Device ID | K802419 |
| 510k Number | K802419 |
| Device Name: | AO NON-CONTACT II TONOMETER |
| Classification | Tonometer, Ac-powered |
| Applicant | AMERICAN OPTICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HKX |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-06 |
| Decision Date | 1980-11-12 |