FDA 510(k)

REVOLVE ENVI 600 高级脂肪系统

K号: K193539 · 2020-05-28

决定日期2020-05-28

产品代码MUU

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

REVOLVE ENVI 600 Advanced Adipose System is the device name listed in this FDA 510(k) record. The listed applicant is Lifecell Corporation. It received FDA 510(k) clearance on 2020-05-28 under 510(k) number K193539. The device is classified under product code MUU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the REVOLVE ENVI 600 Advanced Adipose System?

REVOLVE ENVI 600 Advanced Adipose System is a medical device that received FDA 510(k) clearance on 2020-05-28. The listed applicant is Lifecell Corporation. The 510(k) number is K193539.

When did REVOLVE ENVI 600 Advanced Adipose System receive FDA 510(k) clearance?

REVOLVE ENVI 600 Advanced Adipose System received FDA 510(k) clearance on 2020-05-28, under 510(k) number K193539.

Who is the listed applicant for REVOLVE ENVI 600 Advanced Adipose System?

The FDA 510(k) record lists Lifecell Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REVOLVE ENVI 600 Advanced Adipose System?

The FDA product code for REVOLVE ENVI 600 Advanced Adipose System is MUU.

列明Lifecell Corporation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。

K163647Revolve Envi 600高级脂肪系统 K162752ARTIA 重建组织基质穿孔

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。