FDA 510(k)

디지털 체온계 (모델 QT001)

K-번호: K223044 · 2023-05-10

신청자Shen Zhen Rong Feng Technology Co., Ltd.

결정일2023-05-10

제품 코드FLL

자문 위원회의료장비 규제 텍스트 번역 HO [원문 텍스트가 제공되지 않았기 때문에 번역할 수 없습니다. 원문 텍스트를 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

Digital Thermometer (Model QT001) is the device name listed in this FDA 510(k) record. The listed applicant is Shen Zhen Rong Feng Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-05-10 under 510(k) number K223044. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Digital Thermometer (Model QT001)?

Digital Thermometer (Model QT001) is a medical device that received FDA 510(k) clearance on 2023-05-10. The listed applicant is Shen Zhen Rong Feng Technology Co., Ltd.. The 510(k) number is K223044.

When did Digital Thermometer (Model QT001) receive FDA 510(k) clearance?

Digital Thermometer (Model QT001) received FDA 510(k) clearance on 2023-05-10, under 510(k) number K223044.

Who is the listed applicant for Digital Thermometer (Model QT001)?

The FDA 510(k) record lists Shen Zhen Rong Feng Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital Thermometer (Model QT001)?

The FDA product code for Digital Thermometer (Model QT001) is FLL.

Shen Zhen Rong Feng Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K223037인프라레드 체온계, 모델: IR8807

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