FDA 510(k)

전자 온도계 (XHF2001, XHF2002)

K-번호: K211352 · 2021-09-09

신청자Putian Hanjiang Huafeng Plastic Co., Ltd.

결정일2021-09-09

제품 코드FLL

자문 위원회의료장비 규제 텍스트 번역 HO [원문 텍스트가 제공되지 않았기 때문에 번역할 수 없습니다. 원문 텍스트를 제공해 주시면 번역을 도와드리겠습니다.]

결정Substantially Equivalent

기기 요약

Electronic Thermometer (XHF2001, XHF2002) is the device name listed in this FDA 510(k) record. The listed applicant is Putian Hanjiang Huafeng Plastic Co., Ltd.. It received FDA 510(k) clearance on 2021-09-09 under 510(k) number K211352. 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 Electronic Thermometer (XHF2001, XHF2002)?

Electronic Thermometer (XHF2001, XHF2002) is a medical device that received FDA 510(k) clearance on 2021-09-09. The listed applicant is Putian Hanjiang Huafeng Plastic Co., Ltd.. The 510(k) number is K211352.

When did Electronic Thermometer (XHF2001, XHF2002) receive FDA 510(k) clearance?

Electronic Thermometer (XHF2001, XHF2002) received FDA 510(k) clearance on 2021-09-09, under 510(k) number K211352.

Who is the listed applicant for Electronic Thermometer (XHF2001, XHF2002)?

The FDA 510(k) record lists Putian Hanjiang Huafeng Plastic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electronic Thermometer (XHF2001, XHF2002)?

The FDA product code for Electronic Thermometer (XHF2001, XHF2002) is FLL.

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전자 온도계 (XHF2001, XHF2002)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: FLL)

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