FDA 510(k)

유산 X-Ray 플랫 패널 디텍터 with DROC

K-번호: K210988 · 2021-04-21

결정일2021-04-21

제품 코드MQB

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

결정대체적으로 동일

기기 요약

Yushan X-Ray Flat Panel Detector with DROC is the device name listed in this FDA 510(k) record. The listed applicant is Innocare Optoelectronics Corp.. It received FDA 510(k) clearance on 2021-04-21 under 510(k) number K210988. 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 Yushan X-Ray Flat Panel Detector with DROC?

Yushan X-Ray Flat Panel Detector with DROC is a medical device that received FDA 510(k) clearance on 2021-04-21. The listed applicant is Innocare Optoelectronics Corp.. The 510(k) number is K210988.

When did Yushan X-Ray Flat Panel Detector with DROC receive FDA 510(k) clearance?

Yushan X-Ray Flat Panel Detector with DROC received FDA 510(k) clearance on 2021-04-21, under 510(k) number K210988.

Who is the listed applicant for Yushan X-Ray Flat Panel Detector with DROC?

The FDA 510(k) record lists Innocare Optoelectronics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Yushan X-Ray Flat Panel Detector with DROC?

The FDA product code for Yushan X-Ray Flat Panel Detector with DROC is MQB.

Innocare Optoelectronics Corp.를 신청인으로 등재한 기타 기록

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