FDA 510(k)

babyLance Safety Heelstick (BLM, BLN, BLP)

K-번호: K223900 · 2023-02-24

결정일2023-02-24

제품 코드FMK

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

결정대체적으로 동일

기기 요약

babyLance Safety Heelstick (BLM, BLN, BLP) is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Innovations, LLC. It received FDA 510(k) clearance on 2023-02-24 under 510(k) number K223900. 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 babyLance Safety Heelstick (BLM, BLN, BLP)?

babyLance Safety Heelstick (BLM, BLN, BLP) is a medical device that received FDA 510(k) clearance on 2023-02-24. The listed applicant is Clinical Innovations, LLC. The 510(k) number is K223900.

When did babyLance Safety Heelstick (BLM, BLN, BLP) receive FDA 510(k) clearance?

babyLance Safety Heelstick (BLM, BLN, BLP) received FDA 510(k) clearance on 2023-02-24, under 510(k) number K223900.

Who is the listed applicant for babyLance Safety Heelstick (BLM, BLN, BLP)?

The FDA 510(k) record lists Clinical Innovations, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for babyLance Safety Heelstick (BLM, BLN, BLP)?

The FDA product code for babyLance Safety Heelstick (BLM, BLN, BLP) is FMK.

Clinical Innovations, LLC를 신청인으로 등재한 기타 기록

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