Saans (F4-01-00-000-000)
K号: K251165 · 2026-01-06
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决定日期2026-01-06
产品代码SGR
咨询委员会AN
请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同
器械摘要
Saans (F4-01-00-000-000) is the device name listed in this FDA 510(k) record. The listed applicant is Innaccel Technologies Private Limited. It received FDA 510(k) clearance on 2026-01-06 under 510(k) number K251165. The device is classified under product code SGR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Saans (F4-01-00-000-000)?
Saans (F4-01-00-000-000) is a medical device that received FDA 510(k) clearance on 2026-01-06. The listed applicant is Innaccel Technologies Private Limited. The 510(k) number is K251165.
When did Saans (F4-01-00-000-000) receive FDA 510(k) clearance?
Saans (F4-01-00-000-000) received FDA 510(k) clearance on 2026-01-06, under 510(k) number K251165.
Who is the listed applicant for Saans (F4-01-00-000-000)?
The FDA 510(k) record lists Innaccel Technologies Private Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Saans (F4-01-00-000-000)?
The FDA product code for Saans (F4-01-00-000-000) is SGR.
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：SGR）
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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