FDA 510(k)

BIOK7600 평면 패널探测器

K-번호: K190311 · 2019-03-13

결정일2019-03-13

제품 코드MQB

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

결정대체적으로 동일

기기 요약

BIOK7600 Flat Panel Detector is the device name listed in this FDA 510(k) record. The listed applicant is Biokinemetrics, Inc.. It received FDA 510(k) clearance on 2019-03-13 under 510(k) number K190311. 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 BIOK7600 Flat Panel Detector?

BIOK7600 Flat Panel Detector is a medical device that received FDA 510(k) clearance on 2019-03-13. The listed applicant is Biokinemetrics, Inc.. The 510(k) number is K190311.

When did BIOK7600 Flat Panel Detector receive FDA 510(k) clearance?

BIOK7600 Flat Panel Detector received FDA 510(k) clearance on 2019-03-13, under 510(k) number K190311.

Who is the listed applicant for BIOK7600 Flat Panel Detector?

The FDA 510(k) record lists Biokinemetrics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOK7600 Flat Panel Detector?

The FDA product code for BIOK7600 Flat Panel Detector is MQB.

Biokinemetrics, Inc.를 신청인으로 등재한 기타 기록

K190300BIOK7600W 무선 평면 패널探测器 K181565아크비어스 8600 디지털 라디오그래피 센서

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