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FDA 510(k)

Optomed Smartscope M5 with Optomed Smartscope FA

K-Number: K201325 · 2020-11-20

ApplicantOptomed Oyj
Decision Date2020-11-20
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Optomed Smartscope M5 with Optomed Smartscope FA is a medical device manufactured by Optomed Oyj. It received FDA 510(k) clearance on 2020-11-20 under approval number K201325. 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 Optomed Smartscope M5 with Optomed Smartscope FA?

Optomed Smartscope M5 with Optomed Smartscope FA is a medical device that received FDA 510(k) clearance on 2020-11-20. It is manufactured by Optomed Oyj. The 510(k) number is K201325.

When was Optomed Smartscope M5 with Optomed Smartscope FA approved by the FDA?

Optomed Smartscope M5 with Optomed Smartscope FA received FDA 510(k) clearance on 2020-11-20, under approval number K201325.

What company makes Optomed Smartscope M5 with Optomed Smartscope FA?

Optomed Smartscope M5 with Optomed Smartscope FA is manufactured by Optomed Oyj.

What is the FDA product code for Optomed Smartscope M5 with Optomed Smartscope FA?

The FDA product code for Optomed Smartscope M5 with Optomed Smartscope FA is HKI.

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Official Source

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