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FDA 510(k)

Nano FortiCore, FortiCore

K-Number: K191822 · 2019-10-11

ApplicantNanovis, LLC
Decision Date2019-10-11
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Nano FortiCore, FortiCore is a medical device manufactured by Nanovis, LLC. It received FDA 510(k) clearance on 2019-10-11 under approval number K191822. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nano FortiCore, FortiCore?

Nano FortiCore, FortiCore is a medical device that received FDA 510(k) clearance on 2019-10-11. It is manufactured by Nanovis, LLC. The 510(k) number is K191822.

When was Nano FortiCore, FortiCore approved by the FDA?

Nano FortiCore, FortiCore received FDA 510(k) clearance on 2019-10-11, under approval number K191822.

What company makes Nano FortiCore, FortiCore?

Nano FortiCore, FortiCore is manufactured by Nanovis, LLC.

What is the FDA product code for Nano FortiCore, FortiCore?

The FDA product code for Nano FortiCore, FortiCore is ODP.

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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.