Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)
K号: K232314 · 2023-09-01
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决定日期2023-09-01
产品代码FDS
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2023-09-01 under 510(k) number K232314. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)?
Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is FUJIFILM Healthcare Americas Corporation. The 510(k) number is K232314.
When did Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) receive FDA 510(k) clearance?
Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) received FDA 510(k) clearance on 2023-09-01, under 510(k) number K232314.
Who is the listed applicant for Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)?
The FDA 510(k) record lists FUJIFILM Healthcare Americas Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)?
The FDA product code for Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) is FDS.
列明FUJIFILM Healthcare Americas Corporation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：FDS）
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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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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