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FDA 510(k)

蝴蝶BVM

K号: K243861 · 2025-04-25

申请人Compact Medical, Inc.
决定日期2025-04-25
产品代码BTM
咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同

器械摘要

butterflyBVM is the device name listed in this FDA 510(k) record. The listed applicant is Compact Medical, Inc.. It received FDA 510(k) clearance on 2025-04-25 under 510(k) number K243861. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the butterflyBVM?

butterflyBVM is a medical device that received FDA 510(k) clearance on 2025-04-25. The listed applicant is Compact Medical, Inc.. The 510(k) number is K243861.

When did butterflyBVM receive FDA 510(k) clearance?

butterflyBVM received FDA 510(k) clearance on 2025-04-25, under 510(k) number K243861.

Who is the listed applicant for butterflyBVM?

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

What is the FDA product code for butterflyBVM?

The FDA product code for butterflyBVM is BTM.

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：BTM）

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。

K251631BAG手动复苏器和附件Laerdal Medical ASK221841EOlife®ArcheonK212905Sotair 设备Safe Bvm CorporationK210288一次性手动复苏器Xiamen Compower Medical Tech. Co., Ltd.K181583成人一次性复苏器袋（不带压力释放），成人一次性复苏器袋+压力释放40CMH20，成人一次性复苏器袋+压力释放60CMH20，儿童一次性复苏器袋+压力释放40CMH20，婴儿一次性复苏器袋+压力释放40CMH20Flexicare Medical Limited.K170663Foremount 可弃用PVC复苏器，Foremount 可弃用PEEP 阀，Foremount 可弃用压力计Foremount Enterprise Co., Ltd.

官方来源

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