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FDA 510(k)

Mahana并行数字认知行为疗法（CBT）移动应用程序，用于肠易激综合征（IBS）

K号: K211372 · 2021-06-02

申请人Mahana Therapeutics, Inc.
决定日期2021-06-02
产品代码QMY
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) is the device name listed in this FDA 510(k) record. The listed applicant is Mahana Therapeutics, Inc.. It received FDA 510(k) clearance on 2021-06-02 under 510(k) number K211372. The device is classified under product code QMY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)?

Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) is a medical device that received FDA 510(k) clearance on 2021-06-02. The listed applicant is Mahana Therapeutics, Inc.. The 510(k) number is K211372.

When did Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) receive FDA 510(k) clearance?

Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) received FDA 510(k) clearance on 2021-06-02, under 510(k) number K211372.

Who is the listed applicant for Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)?

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

What is the FDA product code for Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)?

The FDA product code for Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) is QMY.

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

相关器械（代码：QMY）

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。

K211463ReguloraMetame Health, Inc.

官方来源

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