FDA 510(k)

HD80 시리즈 초음파 진단 시스템

K-번호: K233841 · 2024-05-16

신청자Qingdao Hisense Medical Equipment Co., Ltd.

결정일2024-05-16

제품 코드IYN

자문 위원회RA

결정Substantially Equivalent

기기 요약

HD80 Series Ultrasound Diagnostic System is the device name listed in this FDA 510(k) record. The listed applicant is Qingdao Hisense Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2024-05-16 under 510(k) number K233841. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the HD80 Series Ultrasound Diagnostic System?

HD80 Series Ultrasound Diagnostic System is a medical device that received FDA 510(k) clearance on 2024-05-16. The listed applicant is Qingdao Hisense Medical Equipment Co., Ltd.. The 510(k) number is K233841.

When did HD80 Series Ultrasound Diagnostic System receive FDA 510(k) clearance?

HD80 Series Ultrasound Diagnostic System received FDA 510(k) clearance on 2024-05-16, under 510(k) number K233841.

Who is the listed applicant for HD80 Series Ultrasound Diagnostic System?

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

What is the FDA product code for HD80 Series Ultrasound Diagnostic System?

The FDA product code for HD80 Series Ultrasound Diagnostic System is IYN.

Qingdao Hisense Medical Equipment Co., Ltd.를 신청인으로 등재한 기타 기록

K233439HD60 시리즈 초음파 진단 시스템 K222208히사스 LCD 모니터 HMD2C21A, HMD4C27S, HMD6C30D K222132히사이스 LCD 모니터 HMD2G21S, HMD3G21S K221567LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)K213862HD60 시리즈 초음파 진단 시스템 K160347히사이스 LDC 모니터 모델 HMD2G21/HMD3G21/HMD5G21

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