FDA 510(k)

HANAROSTENT 食管TTS (CCC), HANAROSTENT 食管TTS (NCN)

K号: K200860 · 2020-05-20

决定日期2020-05-20

产品代码ESW

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决定实质等同

器械摘要

HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) is the device name listed in this FDA 510(k) record. The listed applicant is M.I.Tech Co., Ltd.. It received FDA 510(k) clearance on 2020-05-20 under 510(k) number K200860. The device is classified under product code ESW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)?

HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) is a medical device that received FDA 510(k) clearance on 2020-05-20. The listed applicant is M.I.Tech Co., Ltd.. The 510(k) number is K200860.

When did HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) receive FDA 510(k) clearance?

HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) received FDA 510(k) clearance on 2020-05-20, under 510(k) number K200860.

Who is the listed applicant for HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)?

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

What is the FDA product code for HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)?

The FDA product code for HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) is ESW.

列明M.I.Tech Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253327HANAROSTENT 食管上段 (CCC)K213251HANAROSTENT 食管非对称 (CCC)K201160HANAROSTENT 食管 (CCC), HANAROSTENT 食管 (NCN)K202973HANAROSTENT Benefit Biliary (NNN)K201342HANAROSTENT 气管/支气管 (CCC)K190141HANAROSTENT 低轴结肠/直肠 (NNN)

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。