FDA 510(k)

인프라레드 체온계

K-번호: K181215 · 2019-01-02

결정일2019-01-02

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 Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Finicare Co., Ltd.. It received FDA 510(k) clearance on 2019-01-02 under 510(k) number K181215. 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 Thermometer?

Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2019-01-02. The listed applicant is Shenzhen Finicare Co., Ltd.. The 510(k) number is K181215.

When did Infrared Thermometer receive FDA 510(k) clearance?

Infrared Thermometer received FDA 510(k) clearance on 2019-01-02, under 510(k) number K181215.

Who is the listed applicant for Infrared Thermometer?

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

What is the FDA product code for Infrared Thermometer?

The FDA product code for Infrared Thermometer is FLL.

Shenzhen Finicare Co., Ltd.를 신청인으로 등재한 기타 기록

K252769Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116)K243136비접촉 전額 인프라레드 체온계 (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)K242721Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131)K231367Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)K220113Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112)

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