FDA 510(k)

플렉스 로봇 시스템 및 플렉스 대장 드라이브

K-번호: K162330 · 2017-05-04

결정일2017-05-04

제품 코드FDF

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Flex Robotic System and Flex Colorectal 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 2017-05-04 under 510(k) number K162330. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Flex Robotic System and Flex Colorectal Drive?

Flex Robotic System and Flex Colorectal Drive is a medical device that received FDA 510(k) clearance on 2017-05-04. The listed applicant is Medrobotics Corporation. The 510(k) number is K162330.

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

Flex Robotic System and Flex Colorectal Drive received FDA 510(k) clearance on 2017-05-04, under 510(k) number K162330.

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

The FDA product code for Flex Robotic System and Flex Colorectal Drive is FDF.

Medrobotics Corporation를 신청인으로 등재한 기타 기록

K172796플렉스 로봇 시스템 및 플렉스 트랜사배드 드라이브 K170453메드로빅스 플렉스 로봇 시스템 K172036메드로빅스 플렉스 로봇 시스템

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