The following data is part of a premarket notification filed by Warner-lambert Co. with the FDA for Ao Docustar(mmiro) Fundus Camera.
| Device ID | K822991 |
| 510k Number | K822991 |
| Device Name: | AO DOCUSTAR(MMIRO) FUNDUS CAMERA |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | WARNER-LAMBERT CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-12 |
| Decision Date | 1983-02-24 |