ExSpiron 1Xi
K号: K162131 · 2017-05-09
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决定日期2017-05-09
产品代码BZK
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。
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器械摘要
ExSpiron 1Xi is the device name listed in this FDA 510(k) record. The listed applicant is Respiratory Motion, Inc.. It received FDA 510(k) clearance on 2017-05-09 under 510(k) number K162131. The device is classified under product code BZK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ExSpiron 1Xi?
ExSpiron 1Xi is a medical device that received FDA 510(k) clearance on 2017-05-09. The listed applicant is Respiratory Motion, Inc.. The 510(k) number is K162131.
When did ExSpiron 1Xi receive FDA 510(k) clearance?
ExSpiron 1Xi received FDA 510(k) clearance on 2017-05-09, under 510(k) number K162131.
Who is the listed applicant for ExSpiron 1Xi?
The FDA 510(k) record lists Respiratory Motion, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ExSpiron 1Xi?
The FDA product code for ExSpiron 1Xi is BZK.
相关临床试验
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列明Respiratory Motion, Inc.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：BZK）
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。
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