FDA 510(k)

iExaminer系统 Panoptic Plus

K号: K223381 · 2023-03-15

决定日期2023-03-15

产品代码HKI

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决定实质等同

器械摘要

iExaminer System with Panoptic Plus is the device name listed in this FDA 510(k) record. The listed applicant is Welch Allyn, Inc.. It received FDA 510(k) clearance on 2023-03-15 under 510(k) number K223381. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the iExaminer System with Panoptic Plus?

iExaminer System with Panoptic Plus is a medical device that received FDA 510(k) clearance on 2023-03-15. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K223381.

When did iExaminer System with Panoptic Plus receive FDA 510(k) clearance?

iExaminer System with Panoptic Plus received FDA 510(k) clearance on 2023-03-15, under 510(k) number K223381.

Who is the listed applicant for iExaminer System with Panoptic Plus?

The FDA 510(k) record lists Welch Allyn, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iExaminer System with Panoptic Plus?

The FDA product code for iExaminer System with Panoptic Plus is HKI.

列明Welch Allyn, Inc.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。

K243598Welch Allyn Connex® 360（多款）K241411Welch Allyn Connex® 即时监测仪；901058 生命体征监测仪核心（CSM）K212473韦尔奇·艾略恩康奈克斯中央站 K191013韦尔奇·艾琳诊断心脏病学套件 2.X.X 带肺功能检测选项 K181016Welch Allyn RetinaVue网络 REF 901108 PACS医学影像系统 K171621韦尔奇·艾利恩 Connex 生命体征监测仪，韦尔奇·艾利恩 Connex 集成式壁挂系统，901060 生命体征监测仪

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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。