i-Sil
K号: K161774 · 2016-09-30
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决定日期2016-09-30
产品代码ELW
咨询委员会DE
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决定实质等同
器械摘要
i-Sil is the device name listed in this FDA 510(k) record. The listed applicant is Spident Co., Ltd.. It received FDA 510(k) clearance on 2016-09-30 under 510(k) number K161774. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the i-Sil?
i-Sil is a medical device that received FDA 510(k) clearance on 2016-09-30. The listed applicant is Spident Co., Ltd.. The 510(k) number is K161774.
When did i-Sil receive FDA 510(k) clearance?
i-Sil received FDA 510(k) clearance on 2016-09-30, under 510(k) number K161774.
Who is the listed applicant for i-Sil?
FDA 510(k)记录将Spident Co., Ltd.列为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for i-Sil?
The FDA product code for i-Sil is ELW.
列明Spident Co., Ltd.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：ELW）
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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