The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for The Keeler All Pupil Indirect Ophthalmoscope.
| Device ID | K854244 |
| 510k Number | K854244 |
| Device Name: | THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE |
| Classification | Ophthalmoscope, Ac-powered |
| 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 | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-21 |
| Decision Date | 1985-11-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055272716765 | K854244 | 000 |
| 05055272712613 | K854244 | 000 |
| 05055272711708 | K854244 | 000 |
| 05055272701341 | K854244 | 000 |
| 05055272701204 | K854244 | 000 |