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FDA 510(k)

ENEO TOTALE (型号：ENEO T947)

K号: K213841 · 2022-01-06

申请人Premier North America, Inc.
决定日期2022-01-06
产品代码OHS
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

ENEO TOTALE (Model: ENEOT947) is the device name listed in this FDA 510(k) record. The listed applicant is Premier North America, Inc.. It received FDA 510(k) clearance on 2022-01-06 under 510(k) number K213841. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ENEO TOTALE (Model: ENEOT947)?

ENEO TOTALE (Model: ENEOT947) is a medical device that received FDA 510(k) clearance on 2022-01-06. The listed applicant is Premier North America, Inc.. The 510(k) number is K213841.

When did ENEO TOTALE (Model: ENEOT947) receive FDA 510(k) clearance?

ENEO TOTALE (Model: ENEOT947) received FDA 510(k) clearance on 2022-01-06, under 510(k) number K213841.

Who is the listed applicant for ENEO TOTALE (Model: ENEOT947)?

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

What is the FDA product code for ENEO TOTALE (Model: ENEOT947)?

The FDA product code for ENEO TOTALE (Model: ENEOT947) is OHS.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Premier North America, 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。

K233862NUNA LUX (NUNL528)K232656BLU TOTALE (型号：ENEOB852)K220735Avologi 凝胶底漆（型号：Av25）K214100LuminiceK181659Avologi ENEO

相关器械（代码：OHS）

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。

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官方来源

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