FDA 510(k)

ENFit 재사용 성인식 주사기

K-번호: K203613 · 2021-08-27

신청자Shantou Wealy Medical Instrument Co.,Ltd

결정일2021-08-27

제품 코드PNR

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

ENFit Reusable Enteral Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Shantou Wealy Medical Instrument Co.,Ltd. It received FDA 510(k) clearance on 2021-08-27 under 510(k) number K203613. 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 ENFit Reusable Enteral Syringe?

ENFit Reusable Enteral Syringe is a medical device that received FDA 510(k) clearance on 2021-08-27. The listed applicant is Shantou Wealy Medical Instrument Co.,Ltd. The 510(k) number is K203613.

When did ENFit Reusable Enteral Syringe receive FDA 510(k) clearance?

ENFit Reusable Enteral Syringe received FDA 510(k) clearance on 2021-08-27, under 510(k) number K203613.

Who is the listed applicant for ENFit Reusable Enteral Syringe?

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

What is the FDA product code for ENFit Reusable Enteral Syringe?

The FDA product code for ENFit Reusable Enteral Syringe is PNR.

Shantou Wealy Medical Instrument Co.,Ltd를 신청인으로 등재한 기타 기록

K222452용기로운 자동 회전 안전 주사기 (분리 가능한針)K210216용기 disposable 자동으로 회전하는 인슐린 안전 주사기 K203410ENFit 사용 가능한 엔터알 수용기 주사기

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