Sentinella 102, Sentinella 102 Horus
K号: K162052 · 2016-08-18
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器械摘要
Sentinella 102, Sentinella 102 Horus is the device name listed in this FDA 510(k) record. The listed applicant is General Equipment For Medical Imaging (Oncovision-. It received FDA 510(k) clearance on 2016-08-18 under 510(k) number K162052. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Sentinella 102, Sentinella 102 Horus?
Sentinella 102, Sentinella 102 Horus is a medical device that received FDA 510(k) clearance on 2016-08-18. The listed applicant is General Equipment For Medical Imaging (Oncovision-. The 510(k) number is K162052.
When did Sentinella 102, Sentinella 102 Horus receive FDA 510(k) clearance?
Sentinella 102, Sentinella 102 Horus received FDA 510(k) clearance on 2016-08-18, under 510(k) number K162052.
Who is the listed applicant for Sentinella 102, Sentinella 102 Horus?
The FDA 510(k) record lists General Equipment For Medical Imaging (Oncovision- as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sentinella 102, Sentinella 102 Horus?
The FDA product code for Sentinella 102, Sentinella 102 Horus is IYX.
相关临床试验
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相关器械（代码：IYX）
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。
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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