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FDA 510(k)

Anura移动核心SDK(M1)

K号: K253650 · 2026-06-11

决定日期2026-06-11
产品代码QME
咨询委员会CV 请注意,由于原文未提供具体内容,以下是一个示例翻译: --- 产品名称:[产品名称] 公司名称:[公司名称] FDA批准号:[FDA批准号] 510(k)申请号:[510(k)申请号] PMA申请号:[PMA申请号] 临床试验注册号:[NCT] PubMed ID:[PMID] 产品标识符:[标识符] 产品URL:[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。
决定实质等同

器械摘要

Anura Mobile Core SDK (M1) is the device name listed in this FDA 510(k) record. The listed applicant is Nuralogix Corporation. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K253650. The device is classified under product code QME. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Anura Mobile Core SDK (M1)?

Anura Mobile Core SDK (M1) is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Nuralogix Corporation. The 510(k) number is K253650.

When did Anura Mobile Core SDK (M1) receive FDA 510(k) clearance?

Anura Mobile Core SDK (M1) received FDA 510(k) clearance on 2026-06-11, under 510(k) number K253650.

Who is the listed applicant for Anura Mobile Core SDK (M1)?

The FDA 510(k) record lists Nuralogix Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anura Mobile Core SDK (M1)?

The FDA product code for Anura Mobile Core SDK (M1) is QME.

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。

相关器械(代码:QME)

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。

官方来源

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