MobileDiagnost wDR 2.2
K号: K191813 · 2019-08-02
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器械摘要
MobileDiagnost wDR 2.2 is the device name listed in this FDA 510(k) record. The listed applicant is Sedecal., Sa.. It received FDA 510(k) clearance on 2019-08-02 under 510(k) number K191813. 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 MobileDiagnost wDR 2.2?
MobileDiagnost wDR 2.2 is a medical device that received FDA 510(k) clearance on 2019-08-02. The listed applicant is Sedecal., Sa.. The 510(k) number is K191813.
When did MobileDiagnost wDR 2.2 receive FDA 510(k) clearance?
MobileDiagnost wDR 2.2 received FDA 510(k) clearance on 2019-08-02, under 510(k) number K191813.
Who is the listed applicant for MobileDiagnost wDR 2.2?
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 MobileDiagnost wDR 2.2?
The FDA product code for MobileDiagnost wDR 2.2 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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