DRAGON X SPSL4HC，DRAGON X SPSL8HC
K号: K173299 · 2018-01-26
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器械摘要
DRAGON X SPSL4HC, DRAGON X SPSL8HC is the device name listed in this FDA 510(k) record. The listed applicant is Sedecal., Sa.. It received FDA 510(k) clearance on 2018-01-26 under 510(k) number K173299. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the DRAGON X SPSL4HC, DRAGON X SPSL8HC?
DRAGON X SPSL4HC, DRAGON X SPSL8HC is a medical device that received FDA 510(k) clearance on 2018-01-26. The listed applicant is Sedecal., Sa.. The 510(k) number is K173299.
When did DRAGON X SPSL4HC, DRAGON X SPSL8HC receive FDA 510(k) clearance?
DRAGON X SPSL4HC, DRAGON X SPSL8HC received FDA 510(k) clearance on 2018-01-26, under 510(k) number K173299.
Who is the listed applicant for DRAGON X SPSL4HC, DRAGON X SPSL8HC?
The FDA 510(k) record lists Sedecal., Sa. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DRAGON X SPSL4HC, DRAGON X SPSL8HC?
The FDA product code for DRAGON X SPSL4HC, DRAGON X SPSL8HC is IZL.
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Sedecal., Sa.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：IZL）
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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