MOBILETT Elara Max
K号: K182639 · 2019-03-15
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器械摘要
MOBILETT Elara Max is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medi Cal Solutions, Inc.. It received FDA 510(k) clearance on 2019-03-15 under 510(k) number K182639. 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 MOBILETT Elara Max?
MOBILETT Elara Max is a medical device that received FDA 510(k) clearance on 2019-03-15. The listed applicant is Siemens Medi Cal Solutions, Inc.. The 510(k) number is K182639.
When did MOBILETT Elara Max receive FDA 510(k) clearance?
MOBILETT Elara Max received FDA 510(k) clearance on 2019-03-15, under 510(k) number K182639.
Who is the listed applicant for MOBILETT Elara Max?
The FDA 510(k) record lists Siemens Medi Cal Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MOBILETT Elara Max?
The FDA product code for MOBILETT Elara Max is IZL.
相关临床试验
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列明Siemens Medi Cal Solutions, Inc.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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