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510(k) K002044

MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT by Magna Fortis Corporation — Product Code HLJ

K002044 is an FDA 510(k) premarket notification submitted by Magna Fortis Corporation for the device "MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT". The FDA issued a decision of Substantially Equivalent on September 12, 2000. The device falls under product code HLJ (Ophthalmoscope, Battery-Powered), a Class II device regulated under 21 CFR 886.1570.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2000
Date Received
July 5, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Battery-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

Other clearances for product code HLJ

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  • K142837 — HEINE SIGMA 250 & HEINE SIGMA 250 M2 (January 29, 2015)
  • K131959 — HEINE MINI 3000(R) OPHTHALMOSCOPE (March 7, 2014)
  • K131961 — HEINE BETA 200(R) OPHTHALMOSCOPE (December 4, 2013)
  • K131719 — OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS (October 30, 2013)
  • K123587 — HEINE MINI 3000 LED OPHTHALMOSCOPE (March 22, 2013)
  • K093495 — OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS (November 19, 2010)
  • K070270 — PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36 (November 5, 2007)
  • K052599 — 66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25 (November 7, 2006)
  • K061278 — OPTYSE OPHTHALMOSCOPE (May 16, 2006)

FDA data resources