Seal Rite 非重复呼吸阀
K号: K152521 · 2016-06-03
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决定日期2016-06-03
产品代码CBP
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
Seal Rite Non-Rebreathing Valve is the device name listed in this FDA 510(k) record. The listed applicant is The Lifeguard Store, Inc.. It received FDA 510(k) clearance on 2016-06-03 under 510(k) number K152521. The device is classified under product code CBP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Seal Rite Non-Rebreathing Valve?
Seal Rite Non-Rebreathing Valve is a medical device that received FDA 510(k) clearance on 2016-06-03. The listed applicant is The Lifeguard Store, Inc.. The 510(k) number is K152521.
When did Seal Rite Non-Rebreathing Valve receive FDA 510(k) clearance?
Seal Rite Non-Rebreathing Valve received FDA 510(k) clearance on 2016-06-03, under 510(k) number K152521.
Who is the listed applicant for Seal Rite Non-Rebreathing Valve?
The FDA 510(k) record lists The Lifeguard Store, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Seal Rite Non-Rebreathing Valve?
The FDA product code for Seal Rite Non-Rebreathing Valve is CBP.
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：CBP）
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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