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FDA 510(k)

Mydriatic Hyperspectral Retinal Camera (MHRC-C1)

K-Number: K200254 · 2020-04-27

ApplicantOptina Diagnostics
Decision Date2020-04-27
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Mydriatic Hyperspectral Retinal Camera (MHRC-C1) is a medical device manufactured by Optina Diagnostics. It received FDA 510(k) clearance on 2020-04-27 under approval number K200254. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mydriatic Hyperspectral Retinal Camera (MHRC-C1)?

Mydriatic Hyperspectral Retinal Camera (MHRC-C1) is a medical device that received FDA 510(k) clearance on 2020-04-27. It is manufactured by Optina Diagnostics. The 510(k) number is K200254.

When was Mydriatic Hyperspectral Retinal Camera (MHRC-C1) approved by the FDA?

Mydriatic Hyperspectral Retinal Camera (MHRC-C1) received FDA 510(k) clearance on 2020-04-27, under approval number K200254.

What company makes Mydriatic Hyperspectral Retinal Camera (MHRC-C1)?

Mydriatic Hyperspectral Retinal Camera (MHRC-C1) is manufactured by Optina Diagnostics.

What is the FDA product code for Mydriatic Hyperspectral Retinal Camera (MHRC-C1)?

The FDA product code for Mydriatic Hyperspectral Retinal Camera (MHRC-C1) is HKI.

Related Clinical Trials

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Official Source

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