FDA 510(k)

IRIS-XP

K 號：K212412 · 2021-09-13

決定日期2021-09-13

產品代碼LHQ

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

IRIS-XP is the device name listed in this FDA 510(k) record. The listed applicant is Medicore Co., Ltd.. It received FDA 510(k) clearance on 2021-09-13 under 510(k) number K212412. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IRIS-XP?

IRIS-XP is a medical device that received FDA 510(k) clearance on 2021-09-13. The listed applicant is Medicore Co., Ltd.. The 510(k) number is K212412.

When did IRIS-XP receive FDA 510(k) clearance?

IRIS-XP received FDA 510(k) clearance on 2021-09-13, under 510(k) number K212412.

Who is the listed applicant for IRIS-XP?

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

What is the FDA product code for IRIS-XP?

The FDA product code for IRIS-XP is LHQ.

相關器械（代碼：LHQ）

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