FDA 510(k)

bowel 관리 장치, bowel 관리 이식 세트

K-번호: K180026 · 2018-06-01

결정일2018-06-01

제품 코드KNT

자문 위원회GU

결정Unknown

기기 요약

Bowel Management Device, Bowel Management Irrigation Set is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Technology, Inc.. It received FDA 510(k) clearance on 2018-06-01 under 510(k) number K180026. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

자주 묻는 질문

What is the Bowel Management Device, Bowel Management Irrigation Set?

Bowel Management Device, Bowel Management Irrigation Set is a medical device that received FDA 510(k) clearance on 2018-06-01. The listed applicant is Applied Medical Technology, Inc.. The 510(k) number is K180026.

When did Bowel Management Device, Bowel Management Irrigation Set receive FDA 510(k) clearance?

Bowel Management Device, Bowel Management Irrigation Set received FDA 510(k) clearance on 2018-06-01, under 510(k) number K180026.

Who is the listed applicant for Bowel Management Device, Bowel Management Irrigation Set?

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

What is the FDA product code for Bowel Management Device, Bowel Management Irrigation Set?

The FDA product code for Bowel Management Device, Bowel Management Irrigation Set is KNT.

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