IODOFLEX
K号: K190756 · 2019-12-20
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器械摘要
IODOFLEX is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical, Ltd.. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K190756. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常见问题
What is the IODOFLEX?
IODOFLEX is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Smith & Nephew Medical, Ltd.. The 510(k) number is K190756.
When did IODOFLEX receive FDA 510(k) clearance?
IODOFLEX received FDA 510(k) clearance on 2019-12-20, under 510(k) number K190756.
Who is the listed applicant for IODOFLEX?
FDA 510(k)记录将史密斯·奈普医疗有限公司列为申请人。这本身并不能确立该设备的制造商。
What is the FDA product code for IODOFLEX?
The FDA product code for IODOFLEX is FRO. This falls under the Anesthesiology category.
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Smith & Nephew Medical, 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：FRO）
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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