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FDA 510(k)

MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT

K-Number: K002044 · 2000-09-12

ApplicantMagna Fortis Corporation
Decision Date2000-09-12
Product CodeHLJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Magna Fortis Corporation. It received FDA 510(k) clearance on 2000-09-12 under 510(k) number K002044. The device is classified under product code HLJ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT?

MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 2000-09-12. The listed applicant is Magna Fortis Corporation. The 510(k) number is K002044.

When did MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT receive FDA 510(k) clearance?

MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT received FDA 510(k) clearance on 2000-09-12, under 510(k) number K002044.

Who is the listed applicant for MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT?

The FDA 510(k) record lists Magna Fortis Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT?

The FDA product code for MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT is HLJ.

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Related Devices (Code: HLJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131961HEINE BETA 200(R) OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGK131719OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITSMedical Devices (Pvt) , Ltd.K123587HEINE MINI 3000 LED OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGK093495OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITSAmerican Diagnostic Corp.K070270PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36Kirchner & Wilhelm GmbH + Co.KgK05259966 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25ASuzhou 66 Vision Tech Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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