FDA 510(k)

Flex机器人系统及Flex经腹驱动器

K号: K172796 · 2018-01-18

决定日期2018-01-18

产品代码HET

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决定实质等同

器械摘要

Flex Robotic System and Flex Transabdominal Drive is the device name listed in this FDA 510(k) record. The listed applicant is Medrobotics Corporation. It received FDA 510(k) clearance on 2018-01-18 under 510(k) number K172796. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Flex Robotic System and Flex Transabdominal Drive?

Flex Robotic System and Flex Transabdominal Drive is a medical device that received FDA 510(k) clearance on 2018-01-18. The listed applicant is Medrobotics Corporation. The 510(k) number is K172796.

When did Flex Robotic System and Flex Transabdominal Drive receive FDA 510(k) clearance?

Flex Robotic System and Flex Transabdominal Drive received FDA 510(k) clearance on 2018-01-18, under 510(k) number K172796.

Who is the listed applicant for Flex Robotic System and Flex Transabdominal Drive?

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

What is the FDA product code for Flex Robotic System and Flex Transabdominal Drive?

The FDA product code for Flex Robotic System and Flex Transabdominal Drive is HET.

列明Medrobotics 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。

K170453Medrobotics Flex 机器人系统 K172036Medrobotics Flex 机器人系统 K162330Flex机器人系统及Flex结直肠癌驱动器

官方来源

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