FDA 510(k)

메디퓨너 랑싱 장치, 모델 번호 LD-E1

K-번호: K231797 · 2023-11-22

결정일2023-11-22

제품 코드QRL

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

Medifun Lancing Device, Model No. LD-E1 is the device name listed in this FDA 510(k) record. The listed applicant is Medifun Corporation. It received FDA 510(k) clearance on 2023-11-22 under 510(k) number K231797. The device is classified under product code QRL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Medifun Lancing Device, Model No. LD-E1?

Medifun Lancing Device, Model No. LD-E1 is a medical device that received FDA 510(k) clearance on 2023-11-22. The listed applicant is Medifun Corporation. The 510(k) number is K231797.

When did Medifun Lancing Device, Model No. LD-E1 receive FDA 510(k) clearance?

Medifun Lancing Device, Model No. LD-E1 received FDA 510(k) clearance on 2023-11-22, under 510(k) number K231797.

Who is the listed applicant for Medifun Lancing Device, Model No. LD-E1?

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

What is the FDA product code for Medifun Lancing Device, Model No. LD-E1?

The FDA product code for Medifun Lancing Device, Model No. LD-E1 is QRL.

Medifun Corporation를 신청인으로 등재한 기타 기록

K241750메디퓰 안전 래닝트 (MSL1 시리즈)

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