FDA 510(k)

디지털 체온계, 모델: DT007, DT008

K-번호: K214077 · 2023-01-20

신청자Guangzhou Berrcom Medical Device Co., Ltd.

결정일2023-01-20

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

Digital Thermometer, Model: DT007, DT008 is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Berrcom Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2023-01-20 under 510(k) number K214077. 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 Digital Thermometer, Model: DT007, DT008?

Digital Thermometer, Model: DT007, DT008 is a medical device that received FDA 510(k) clearance on 2023-01-20. The listed applicant is Guangzhou Berrcom Medical Device Co., Ltd.. The 510(k) number is K214077.

When did Digital Thermometer, Model: DT007, DT008 receive FDA 510(k) clearance?

Digital Thermometer, Model: DT007, DT008 received FDA 510(k) clearance on 2023-01-20, under 510(k) number K214077.

Who is the listed applicant for Digital Thermometer, Model: DT007, DT008?

The FDA 510(k) record lists Guangzhou Berrcom Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital Thermometer, Model: DT007, DT008?

The FDA product code for Digital Thermometer, Model: DT007, DT008 is FLL.

Guangzhou Berrcom Medical Device Co., Ltd.를 신청인으로 등재한 기타 기록

K213746디지털 체온계, 모델 DT101, DT102 K213084이어 온도계, 모델 ET005, ET008, ET009 K213079이어온도계, 모델 ET001 K213082Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 K191570인프라레드 체온계 모델 MD-H30

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