FDA 510(k)

포커스 35C 탐지기, 트리맥스 35C 탐지기

K-번호: K192512 · 2019-10-16

결정일2019-10-16

제품 코드MQB

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

결정대체적으로 동일

기기 요약

Focus 35C Detector, Trimax 35C Detector is the device name listed in this FDA 510(k) record. The listed applicant is Iray Technology Taicang , Ltd.. It received FDA 510(k) clearance on 2019-10-16 under 510(k) number K192512. 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 Focus 35C Detector, Trimax 35C Detector?

Focus 35C Detector, Trimax 35C Detector is a medical device that received FDA 510(k) clearance on 2019-10-16. The listed applicant is Iray Technology Taicang , Ltd.. The 510(k) number is K192512.

When did Focus 35C Detector, Trimax 35C Detector receive FDA 510(k) clearance?

Focus 35C Detector, Trimax 35C Detector received FDA 510(k) clearance on 2019-10-16, under 510(k) number K192512.

Who is the listed applicant for Focus 35C Detector, Trimax 35C Detector?

The FDA 510(k) record lists Iray Technology Taicang , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Focus 35C Detector, Trimax 35C Detector?

The FDA product code for Focus 35C Detector, Trimax 35C Detector is MQB.

Iray Technology Taicang , Ltd.를 신청인으로 등재한 기타 기록

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