HealthOST
K号: K213944 · 2022-04-22
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器械摘要
HealthOST is the device name listed in this FDA 510(k) record. The listed applicant is Nanoxai , Ltd.. It received FDA 510(k) clearance on 2022-04-22 under 510(k) number K213944. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the HealthOST?
HealthOST is a medical device that received FDA 510(k) clearance on 2022-04-22. The listed applicant is Nanoxai , Ltd.. The 510(k) number is K213944.
When did HealthOST receive FDA 510(k) clearance?
HealthOST received FDA 510(k) clearance on 2022-04-22, under 510(k) number K213944.
Who is the listed applicant for HealthOST?
The FDA 510(k) record lists Nanoxai , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HealthOST?
The FDA product code for HealthOST is JAK.
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相关器械(代码:JAK)
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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