SafeBreath过滤器口嘴
K号: K190022 · 2019-09-25
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决定日期2019-09-25
产品代码CAH
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
SafeBreath Filter Mouthpiece is the device name listed in this FDA 510(k) record. The listed applicant is MD Diagnostics Limited. It received FDA 510(k) clearance on 2019-09-25 under 510(k) number K190022. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SafeBreath Filter Mouthpiece?
SafeBreath Filter Mouthpiece is a medical device that received FDA 510(k) clearance on 2019-09-25. The listed applicant is MD Diagnostics Limited. The 510(k) number is K190022.
When did SafeBreath Filter Mouthpiece receive FDA 510(k) clearance?
SafeBreath Filter Mouthpiece received FDA 510(k) clearance on 2019-09-25, under 510(k) number K190022.
Who is the listed applicant for SafeBreath Filter Mouthpiece?
The FDA 510(k) record lists MD Diagnostics Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SafeBreath Filter Mouthpiece?
The FDA product code for SafeBreath Filter Mouthpiece is CAH.
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。
列明MD Diagnostics Limited为申报人的其他记录
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：CAH）
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。
K252643Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledTeleflex Medical Sdn. Bhd.K251583Ambu® Virobac II® 呼气过滤器Ambu A/SK241339Besmed 细菌过滤器和高流量湿化器Besmed Health Business CorpK222917呼吸回路细菌/病毒过滤器Shaoxing Haitech Medical Products Co., Ltd.K230483Passy Muir 气管切开术病毒和细菌气道保护过滤器（PM-APF15）Passy-Muir, Inc.K223258TNI Clear-Guard® 3角位呼吸过滤器（1545020）Intersurgical , Ltd.
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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