FDA 510(k)

Diversatek Healthcare PureFlo 이식 시스템 / 물병 튜브

K-번호: K222734 · 2022-11-08

결정일2022-11-08

제품 코드OCX

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Substantially Equivalent

기기 요약

Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing is the device name listed in this FDA 510(k) record. The listed applicant is Diversatek Healthcare. It received FDA 510(k) clearance on 2022-11-08 under 510(k) number K222734. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing?

Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing is a medical device that received FDA 510(k) clearance on 2022-11-08. The listed applicant is Diversatek Healthcare. The 510(k) number is K222734.

When did Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing receive FDA 510(k) clearance?

Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing received FDA 510(k) clearance on 2022-11-08, under 510(k) number K222734.

Who is the listed applicant for Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing?

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

What is the FDA product code for Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing?

The FDA product code for Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing is OCX.

Diversatek Healthcare를 신청인으로 등재한 기타 기록

K230056미비우™ 식도 엔도 캡 K190208Diversatek Healthcare 고해해상도 저항도만ometry (HRiM) Probe

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