FDA 510(k)

INNI-CERA

K 號：K211308 · 2021-10-04

決定日期2021-10-04

產品代碼EIH

諮詢委員會DE

決定相當於

器材摘要

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

常見問題

What is the INNI-CERA?

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

When did INNI-CERA receive FDA 510(k) clearance?

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

Who is the listed applicant for INNI-CERA?

The FDA 510(k) record lists Aon Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INNI-CERA?

The FDA product code for INNI-CERA is EIH.

相關器械（代碼：EIH）

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