The following data is part of a premarket notification filed by Magna Fortis Corporation with the FDA for Magna Fortis Ophthalmoscope Diagnostic Kit.
| Device ID | K002044 |
| 510k Number | K002044 |
| Device Name: | MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT |
| Classification | Ophthalmoscope, Battery-powered |
| Applicant | MAGNA FORTIS CORPORATION 13606 N.E. 20 ST. Bellevue, WA 98005 |
| Contact | Mark Werblud |
| Correspondent | Mark Werblud MAGNA FORTIS CORPORATION 13606 N.E. 20 ST. Bellevue, WA 98005 |
| Product Code | HLJ |
| Subsequent Product Code | CCW |
| Subsequent Product Code | EOB |
| Subsequent Product Code | ERA |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-05 |
| Decision Date | 2000-09-12 |