The following data is part of a premarket notification filed by Keller Instruments, Inc. with the FDA for Spectacle Indirect Ophthalmoscope.
| Device ID | K841292 |
| 510k Number | K841292 |
| Device Name: | SPECTACLE INDIRECT OPHTHALMOSCOPE |
| Classification | Ophthalmoscope, Battery-powered |
| Applicant | KELLER INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HLJ |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-29 |
| Decision Date | 1984-05-09 |