Enovare 超声系统
K号: K153620 · 2016-05-05
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器械摘要
Enovare Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Oreon Technologies, Inc.. It received FDA 510(k) clearance on 2016-05-05 under 510(k) number K153620. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Enovare Ultrasound System?
Enovare Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-05-05. The listed applicant is Oreon Technologies, Inc.. The 510(k) number is K153620.
When did Enovare Ultrasound System receive FDA 510(k) clearance?
Enovare Ultrasound System received FDA 510(k) clearance on 2016-05-05, under 510(k) number K153620.
Who is the listed applicant for Enovare Ultrasound System?
The FDA 510(k) record lists Oreon Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Enovare Ultrasound System?
The FDA product code for Enovare Ultrasound System is IYO.
相关临床试验
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相关器械（代码：IYO）
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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