SpiroHome Personal, SpiroHome Clinic
K号: K213754 · 2023-06-12
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决定日期2023-06-12
产品代码BZG
咨询委员会AN
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决定实质等同
器械摘要
SpiroHome Personal, SpiroHome Clinic is the device name listed in this FDA 510(k) record. The listed applicant is Inofab Saglik Teknolojileri A.S. It received FDA 510(k) clearance on 2023-06-12 under 510(k) number K213754. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SpiroHome Personal, SpiroHome Clinic?
SpiroHome Personal, SpiroHome Clinic is a medical device that received FDA 510(k) clearance on 2023-06-12. The listed applicant is Inofab Saglik Teknolojileri A.S. The 510(k) number is K213754.
When did SpiroHome Personal, SpiroHome Clinic receive FDA 510(k) clearance?
SpiroHome Personal, SpiroHome Clinic received FDA 510(k) clearance on 2023-06-12, under 510(k) number K213754.
Who is the listed applicant for SpiroHome Personal, SpiroHome Clinic?
The FDA 510(k) record lists Inofab Saglik Teknolojileri A.S as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SpiroHome Personal, SpiroHome Clinic?
The FDA product code for SpiroHome Personal, SpiroHome Clinic is BZG.
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：BZG）
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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