FDA 510(k)

인프라레드 전額 Thermometer, 모델 JZK-601, JZK-602, JZK-603

K-번호: K203707 · 2021-03-12

신청자Shenzhen Zhengkang Technology Co., Ltd.

결정일2021-03-12

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

Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Zhengkang Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-03-12 under 510(k) number K203707. 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 Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603?

Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 is a medical device that received FDA 510(k) clearance on 2021-03-12. The listed applicant is Shenzhen Zhengkang Technology Co., Ltd.. The 510(k) number is K203707.

When did Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 receive FDA 510(k) clearance?

Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 received FDA 510(k) clearance on 2021-03-12, under 510(k) number K203707.

Who is the listed applicant for Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603?

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

What is the FDA product code for Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603?

The FDA product code for Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 is FLL.

Shenzhen Zhengkang Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K213984산소饱和도 측정기 (모델: JZK-301, JZK-303, JZK-305, JZK-307)K191894상臂 혈압 모니터

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.