The following data is part of a premarket notification filed by American Optical Corp. with the FDA for A O Custom Ii Chair And Stand.
| Device ID | K801638 |
| 510k Number | K801638 |
| Device Name: | A O CUSTOM II CHAIR AND STAND |
| Classification | Chair, Ophthalmic, Ac-powered |
| Applicant | AMERICAN OPTICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HME |
| CFR Regulation Number | 886.1140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-17 |
| Decision Date | 1980-08-13 |