The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Henson Cfa 3000 Central Visual Field Screener.
| Device ID | K891610 |
| 510k Number | K891610 |
| Device Name: | HENSON CFA 3000 CENTRAL VISUAL FIELD SCREENER |
| Classification | Clamp, Eyelid, Ophthalmic |
| Applicant | KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Contact | Van Arsdale |
| Correspondent | Van Arsdale KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Product Code | HOD |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-20 |
| Decision Date | 1989-06-05 |