便携式网状雾化器（JM821）
K号: K244035 · 2025-09-19
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决定日期2025-09-19
产品代码CAF
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
Portable mesh nebulizer (JM821) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Jermei Medical Device Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K244035. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Portable mesh nebulizer (JM821)?
Portable mesh nebulizer (JM821) is a medical device that received FDA 510(k) clearance on 2025-09-19. The listed applicant is Shenzhen Jermei Medical Device Technology Co., Ltd.. The 510(k) number is K244035.
When did Portable mesh nebulizer (JM821) receive FDA 510(k) clearance?
Portable mesh nebulizer (JM821) received FDA 510(k) clearance on 2025-09-19, under 510(k) number K244035.
Who is the listed applicant for Portable mesh nebulizer (JM821)?
The FDA 510(k) record lists Shenzhen Jermei Medical Device Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Portable mesh nebulizer (JM821)?
The FDA product code for Portable mesh nebulizer (JM821) is CAF.
相关临床试验
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相关器械（代码：CAF）
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
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。
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