FDA 510(k)

STAT 의료장비 창상시스템

K-번호: K230310 · 2023-09-08

결정일2023-09-08

제품 코드QRK

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

결정대체적으로 동일

기기 요약

STAT Medical Device Lancing System is the device name listed in this FDA 510(k) record. The listed applicant is Stat Medical Devices. It received FDA 510(k) clearance on 2023-09-08 under 510(k) number K230310. The device is classified under product code QRK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the STAT Medical Device Lancing System?

STAT Medical Device Lancing System is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is Stat Medical Devices. The 510(k) number is K230310.

When did STAT Medical Device Lancing System receive FDA 510(k) clearance?

STAT Medical Device Lancing System received FDA 510(k) clearance on 2023-09-08, under 510(k) number K230310.

Who is the listed applicant for STAT Medical Device Lancing System?

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

What is the FDA product code for STAT Medical Device Lancing System?

The FDA product code for STAT Medical Device Lancing System is QRK.

Stat Medical Devices를 신청인으로 등재한 기타 기록

K222617EasyTouch 창상 장비 K223815원락 랑싱 장치

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