The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Medic Lux Diagnostic Sets.
| Device ID | K832437 |
| 510k Number | K832437 |
| Device Name: | MEDIC LUX DIAGNOSTIC SETS |
| Classification | Ophthalmoscope, Battery-powered |
| Applicant | KEELER 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 | 1983-07-25 |
| Decision Date | 1983-08-16 |