FDA 510(k)

영양수유 시릴(ENfit 커넥터 포함; 모델: 10 ml; 60 ml 제어링 반지)

K-번호: K200557 · 2020-09-28

신청자Jiangsu Shenli Medical Production Co., Ltd.

결정일2020-09-28

제품 코드PNR

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Shenli Medical Production Co., Ltd.. It received FDA 510(k) clearance on 2020-09-28 under 510(k) number K200557. The device is classified under product code PNR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)?

Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) is a medical device that received FDA 510(k) clearance on 2020-09-28. The listed applicant is Jiangsu Shenli Medical Production Co., Ltd.. The 510(k) number is K200557.

When did Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) receive FDA 510(k) clearance?

Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) received FDA 510(k) clearance on 2020-09-28, under 510(k) number K200557.

Who is the listed applicant for Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)?

The FDA 510(k) record lists Jiangsu Shenli Medical Production Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)?

The FDA product code for Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) is PNR.

Jiangsu Shenli Medical Production Co., Ltd.를 신청인으로 등재한 기타 기록

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