FDA 510(k)

Advocate 비접촉 인프라레드 체온계

K-번호: K180355 · 2019-01-10

결정일2019-01-10

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

Advocate Non-Contact Infrared Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Broadmaster Biotech, Corp.. It received FDA 510(k) clearance on 2019-01-10 under 510(k) number K180355. 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 Advocate Non-Contact Infrared Thermometer?

Advocate Non-Contact Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2019-01-10. The listed applicant is Broadmaster Biotech, Corp.. The 510(k) number is K180355.

When did Advocate Non-Contact Infrared Thermometer receive FDA 510(k) clearance?

Advocate Non-Contact Infrared Thermometer received FDA 510(k) clearance on 2019-01-10, under 510(k) number K180355.

Who is the listed applicant for Advocate Non-Contact Infrared Thermometer?

The FDA 510(k) record lists Broadmaster Biotech, Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Advocate Non-Contact Infrared Thermometer?

The FDA product code for Advocate Non-Contact Infrared Thermometer is FLL.

Broadmaster Biotech, Corp.를 신청인으로 등재한 기타 기록

K191004Advocate 비접촉 인프라레드 체온계

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