内镜氧气面罩
K号: K220533 · 2022-11-16
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决定日期2022-11-16
产品代码CCK
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
Endoscopy Oxygen Mask is the device name listed in this FDA 510(k) record. The listed applicant is Engineered Medical Systems, Inc.. It received FDA 510(k) clearance on 2022-11-16 under 510(k) number K220533. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Endoscopy Oxygen Mask?
Endoscopy Oxygen Mask is a medical device that received FDA 510(k) clearance on 2022-11-16. The listed applicant is Engineered Medical Systems, Inc.. The 510(k) number is K220533.
When did Endoscopy Oxygen Mask receive FDA 510(k) clearance?
Endoscopy Oxygen Mask received FDA 510(k) clearance on 2022-11-16, under 510(k) number K220533.
Who is the listed applicant for Endoscopy Oxygen Mask?
The FDA 510(k) record lists Engineered Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Endoscopy Oxygen Mask?
The FDA product code for Endoscopy Oxygen Mask is CCK.
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。
相关器械（代码：CCK）
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。
K251641GF-310R 多气体单元（GF-310R）Nihon Kohden CorporationK261633视呼吸Affirm Medical Technologies II, LLCK253030Capnostream™35 便携式呼吸监测仪 (PM35MN)Covidien, LLCK250148医疗气体分析仪（AG200）Prior Care Science Technology, Ltd.K243956TG-980P CO2 传感器套件 (TG-980P); TG-980P1 CO2 传感器套件 (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 样品线；0184T CO2 样品线；0139 CO2 样品线；0182 CO2 样品线Barbaras Development, Inc.
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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