FDA 510(k)

PureLift

K号: K190269 · 2019-08-28

决定日期2019-08-28

产品代码NFO

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决定实质等同

器械摘要

PureLift is the device name listed in this FDA 510(k) record. The listed applicant is Xtreem Pulse, LLC. It received FDA 510(k) clearance on 2019-08-28 under 510(k) number K190269. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PureLift?

PureLift is a medical device that received FDA 510(k) clearance on 2019-08-28. The listed applicant is Xtreem Pulse, LLC. The 510(k) number is K190269.

When did PureLift receive FDA 510(k) clearance?

PureLift received FDA 510(k) clearance on 2019-08-28, under 510(k) number K190269.

Who is the listed applicant for PureLift?

FDA 510(k)记录显示Xtreem Pulse, LLC为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for PureLift?

The FDA product code for PureLift is NFO.

列明Xtreem Pulse, LLC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。

K262861PureLift Pro Max K243587PureLift GLOW K221443PureLift Pro Plus K173483Pure Flow 外部反搏装置

官方来源

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