FDA 510(k)

X-라이프 플랫 패널 디터ktör (CareView 1800Cwe /CareView 1500Cwe)

K-번호: K201932 · 2020-08-07

신청자Careray Digital Medical System Co., Ltd.

결정일2020-08-07

제품 코드MQB

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) is the device name listed in this FDA 510(k) record. The listed applicant is Careray Digital Medical System Co., Ltd.. It received FDA 510(k) clearance on 2020-08-07 under 510(k) number K201932. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)?

X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) is a medical device that received FDA 510(k) clearance on 2020-08-07. The listed applicant is Careray Digital Medical System Co., Ltd.. The 510(k) number is K201932.

When did X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) receive FDA 510(k) clearance?

X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) received FDA 510(k) clearance on 2020-08-07, under 510(k) number K201932.

Who is the listed applicant for X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)?

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

What is the FDA product code for X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)?

The FDA product code for X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) is MQB.

Careray Digital Medical System Co., Ltd.를 신청인으로 등재한 기타 기록

K202995X-라이프 플랫 패널 디터커/CareView 3600RF K193173CareView 1800Le K172581CareView 1800Cw X-선 평면 패널探测器 K163019CareView 750Cw/750C X-라이프 플랫 패널探测器 K162178CareView 1500P X-레이 평면 패널探测器

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.