DCM (PW-DCM)
K号: K243513 · 2025-04-16
广告
决定日期2025-04-16
产品代码LEL
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
DCM (PW-DCM) is the device name listed in this FDA 510(k) record. The listed applicant is Pneumowave, Ltd.. It received FDA 510(k) clearance on 2025-04-16 under 510(k) number K243513. The device is classified under product code LEL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the DCM (PW-DCM)?
DCM (PW-DCM) is a medical device that received FDA 510(k) clearance on 2025-04-16. The listed applicant is Pneumowave, Ltd.. The 510(k) number is K243513.
When did DCM (PW-DCM) receive FDA 510(k) clearance?
DCM (PW-DCM) received FDA 510(k) clearance on 2025-04-16, under 510(k) number K243513.
Who is the listed applicant for DCM (PW-DCM)?
The FDA 510(k) record lists Pneumowave, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DCM (PW-DCM)?
The FDA product code for DCM (PW-DCM) is LEL.
相关器械（代码：LEL）
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
在 FDA 数据库中查看 →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。
广告