FDA 510(k)

메디퓰 안전 래닝트 (MSL1 시리즈)

K-번호: K241750 · 2024-08-15

결정일2024-08-15

제품 코드FMK

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

결정대체적으로 동일

기기 요약

Medifun Safety Lancet ( MSL1 series) is the device name listed in this FDA 510(k) record. The listed applicant is Medifun Corporation. It received FDA 510(k) clearance on 2024-08-15 under 510(k) number K241750. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Medifun Safety Lancet ( MSL1 series)?

Medifun Safety Lancet ( MSL1 series) is a medical device that received FDA 510(k) clearance on 2024-08-15. The listed applicant is Medifun Corporation. The 510(k) number is K241750.

When did Medifun Safety Lancet ( MSL1 series) receive FDA 510(k) clearance?

Medifun Safety Lancet ( MSL1 series) received FDA 510(k) clearance on 2024-08-15, under 510(k) number K241750.

Who is the listed applicant for Medifun Safety Lancet ( MSL1 series)?

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 Safety Lancet ( MSL1 series)?

The FDA product code for Medifun Safety Lancet ( MSL1 series) is FMK.

Medifun Corporation를 신청인으로 등재한 기타 기록

K231797메디퓨너 랑싱 장치, 모델 번호 LD-E1

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