FDA 510(k)

Intelligent NR

K-Number: K212269 · 2021-09-17

Decision Date2021-09-17

Product CodeMQB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Intelligent NR is a medical device manufactured by Canon, Inc.. It received FDA 510(k) clearance on 2021-09-17 under approval number K212269. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intelligent NR?

Intelligent NR is a medical device that received FDA 510(k) clearance on 2021-09-17. It is manufactured by Canon, Inc.. The 510(k) number is K212269.

When was Intelligent NR approved by the FDA?

Intelligent NR received FDA 510(k) clearance on 2021-09-17, under approval number K212269.

What company makes Intelligent NR?

Intelligent NR is manufactured by Canon, Inc..

What is the FDA product code for Intelligent NR?

The FDA product code for Intelligent NR is MQB.

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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.