SDF Pro
K号: K250222 · 2025-05-07
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决定日期2025-05-07
产品代码PHR
咨询委员会DE
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器械摘要
SDF Pro is the device name listed in this FDA 510(k) record. The listed applicant is Belport Company, Inc., Gingi-Pak. It received FDA 510(k) clearance on 2025-05-07 under 510(k) number K250222. The device is classified under product code PHR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SDF Pro?
SDF Pro is a medical device that received FDA 510(k) clearance on 2025-05-07. The listed applicant is Belport Company, Inc., Gingi-Pak. The 510(k) number is K250222.
When did SDF Pro receive FDA 510(k) clearance?
SDF Pro received FDA 510(k) clearance on 2025-05-07, under 510(k) number K250222.
Who is the listed applicant for SDF Pro?
The FDA 510(k) record lists Belport Company, Inc., Gingi-Pak as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SDF Pro?
The FDA product code for SDF Pro is PHR.
列明Belport Company, Inc., Gingi-Pak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：PHR）
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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