MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT— 510(k) K002044

Name: FDA 510(k) clearance K002044
Creator: U.S. Food and Drug Administration
Published: 2000-09-12

Substantially Equivalent

Magna Fortis Corporation

FDA 510(k) clearance K002044 for MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT, Substantially Equivalent on 2000-09-12. Applicant: Magna Fortis Corporation. Device class: 2.

Clearance details

Applicant: Magna Fortis Corporation
Product code: Code HLJ
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2000-07-05
Decision date: 2000-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.