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 |