FDA 510(k)

인프라레드 비접촉 온도계, 모델 ACT8100

K-번호: K162509 · 2017-03-10

결정일2017-03-10

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

Infrared Non-contact Thermometer, Model ACT8100 is the device name listed in this FDA 510(k) record. The listed applicant is Easywell Biomedicals, Inc.. It received FDA 510(k) clearance on 2017-03-10 under 510(k) number K162509. 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 Non-contact Thermometer, Model ACT8100?

Infrared Non-contact Thermometer, Model ACT8100 is a medical device that received FDA 510(k) clearance on 2017-03-10. The listed applicant is Easywell Biomedicals, Inc.. The 510(k) number is K162509.

When did Infrared Non-contact Thermometer, Model ACT8100 receive FDA 510(k) clearance?

Infrared Non-contact Thermometer, Model ACT8100 received FDA 510(k) clearance on 2017-03-10, under 510(k) number K162509.

Who is the listed applicant for Infrared Non-contact Thermometer, Model ACT8100?

The FDA 510(k) record lists Easywell Biomedicals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infrared Non-contact Thermometer, Model ACT8100?

The FDA product code for Infrared Non-contact Thermometer, Model ACT8100 is FLL.

Easywell Biomedicals, Inc.를 신청인으로 등재한 기타 기록

K163166EASYWELL TENS 시스템 TENS 및 열, EASYWELL TENS 시스템 TENS 만

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