FDA 510(k)

엑스택 외부 배출 및 모니터링 시스템, 엑스택 레이저 레벨 포스트, 엑스택 시스템 대체 배출 백, 대체 레이저 레벨

K-번호: K201118 · 2020-05-26

결정일2020-05-26

제품 코드GWM

자문 위원회NE (이 문서는 원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.)

결정Substantially Equivalent

기기 요약

Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2020-05-26 under 510(k) number K201118. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level?

Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level is a medical device that received FDA 510(k) clearance on 2020-05-26. The listed applicant is Medtronic, Inc.. The 510(k) number is K201118.

When did Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level receive FDA 510(k) clearance?

Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level received FDA 510(k) clearance on 2020-05-26, under 510(k) number K201118.

Who is the listed applicant for Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level?

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

What is the FDA product code for Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level?

The FDA product code for Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level is GWM.