FDA 510(k)

비접촉 전額 체온계

K-번호: K173048 · 2018-12-06

신청자Dongguan Simzo Electronic Technology Co., Ltd.

결정일2018-12-06

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

No-contact Forehead Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Simzo Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-12-06 under 510(k) number K173048. 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 No-contact Forehead Thermometer?

No-contact Forehead Thermometer is a medical device that received FDA 510(k) clearance on 2018-12-06. The listed applicant is Dongguan Simzo Electronic Technology Co., Ltd.. The 510(k) number is K173048.

When did No-contact Forehead Thermometer receive FDA 510(k) clearance?

No-contact Forehead Thermometer received FDA 510(k) clearance on 2018-12-06, under 510(k) number K173048.

Who is the listed applicant for No-contact Forehead Thermometer?

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

What is the FDA product code for No-contact Forehead Thermometer?

The FDA product code for No-contact Forehead Thermometer is FLL.

Dongguan Simzo Electronic Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K230379포터블(초음파) 분말기 K211583인프라레드 체온계, 모델: HW-1

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