The following data is part of a premarket notification filed by Kowa Optimed, Inc. with the FDA for Automatic Visual Field Plotter Ap-125.
| Device ID | K961090 |
| 510k Number | K961090 |
| Device Name: | AUTOMATIC VISUAL FIELD PLOTTER AP-125 |
| Classification | Perimeter, Automatic, Ac-powered |
| Applicant | KOWA OPTIMED, INC. 700 THIRTEENTH STREET, N.W. SUITE 1200 Washington, DC 20005 |
| Contact | Hiroshi Okada |
| Correspondent | Hiroshi Okada KOWA OPTIMED, INC. 700 THIRTEENTH STREET, N.W. SUITE 1200 Washington, DC 20005 |
| Product Code | HPT |
| CFR Regulation Number | 886.1605 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-19 |
| Decision Date | 1996-06-17 |