ZAFIRA®
K号: K254245 · 2026-03-03
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决定日期2026-03-03
产品代码EBF
咨询委员会DE
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器械摘要
ZAFIRA® is the device name listed in this FDA 510(k) record. The listed applicant is New Stetic, SA. It received FDA 510(k) clearance on 2026-03-03 under 510(k) number K254245. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ZAFIRA®?
ZAFIRA® is a medical device that received FDA 510(k) clearance on 2026-03-03. The listed applicant is New Stetic, SA. The 510(k) number is K254245.
When did ZAFIRA® receive FDA 510(k) clearance?
ZAFIRA® received FDA 510(k) clearance on 2026-03-03, under 510(k) number K254245.
Who is the listed applicant for ZAFIRA®?
The FDA 510(k) record lists New Stetic, SA as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ZAFIRA®?
The FDA product code for ZAFIRA® is EBF.
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。
列明New Stetic, SA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：EBF）
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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