Elemental 粒状物
K号: K241283 · 2025-01-03
广告
器械摘要
Elemental Granulate is the device name listed in this FDA 510(k) record. The listed applicant is Zinkh NV. It received FDA 510(k) clearance on 2025-01-03 under 510(k) number K241283. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.
常见问题
What is the Elemental Granulate?
Elemental Granulate is a medical device that received FDA 510(k) clearance on 2025-01-03. The listed applicant is Zinkh NV. The 510(k) number is K241283.
When did Elemental Granulate receive FDA 510(k) clearance?
Elemental Granulate received FDA 510(k) clearance on 2025-01-03, under 510(k) number K241283.
Who is the listed applicant for Elemental Granulate?
The FDA 510(k) record lists Zinkh NV as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Elemental Granulate?
The FDA product code for Elemental Granulate is OLR.
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:OLR)
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。
广告