Allura Xper R9
K号: K162148 · 2016-11-23
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器械摘要
Allura Xper R9 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nethrlands BV. It received FDA 510(k) clearance on 2016-11-23 under 510(k) number K162148. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Allura Xper R9?
Allura Xper R9 is a medical device that received FDA 510(k) clearance on 2016-11-23. The listed applicant is Philips Medical Systems Nethrlands BV. The 510(k) number is K162148.
When did Allura Xper R9 receive FDA 510(k) clearance?
Allura Xper R9 received FDA 510(k) clearance on 2016-11-23, under 510(k) number K162148.
Who is the listed applicant for Allura Xper R9?
The FDA 510(k) record lists Philips Medical Systems Nethrlands BV as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Allura Xper R9?
The FDA product code for Allura Xper R9 is OWB.
相关临床试验
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相关器械（代码：OWB）
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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