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FDA 510(k)

INNI-CERA

K-Number: K211308 · 2021-10-04

ApplicantAon Co., Ltd.
Decision Date2021-10-04
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INNI-CERA is a medical device manufactured by Aon Co., Ltd.. It received FDA 510(k) clearance on 2021-10-04 under approval number K211308. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNI-CERA?

INNI-CERA is a medical device that received FDA 510(k) clearance on 2021-10-04. It is manufactured by Aon Co., Ltd.. The 510(k) number is K211308.

When was INNI-CERA approved by the FDA?

INNI-CERA received FDA 510(k) clearance on 2021-10-04, under approval number K211308.

What company makes INNI-CERA?

INNI-CERA is manufactured by Aon Co., Ltd..

What is the FDA product code for INNI-CERA?

The FDA product code for INNI-CERA is EIH.

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Official Source

View on FDA Database →

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

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