FDA 510(k)

오티스 광결절 톤오풀기 시스템

K-번호: K190404 · 2019-03-26

결정일2019-03-26

제품 코드NQQ

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

결정대체적으로 동일

기기 요약

OTIS Optical Coherence Tomography SYstem is the device name listed in this FDA 510(k) record. The listed applicant is Perimeter Medical Imaging, Inc.. It received FDA 510(k) clearance on 2019-03-26 under 510(k) number K190404. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the OTIS Optical Coherence Tomography SYstem?

OTIS Optical Coherence Tomography SYstem is a medical device that received FDA 510(k) clearance on 2019-03-26. The listed applicant is Perimeter Medical Imaging, Inc.. The 510(k) number is K190404.

When did OTIS Optical Coherence Tomography SYstem receive FDA 510(k) clearance?

OTIS Optical Coherence Tomography SYstem received FDA 510(k) clearance on 2019-03-26, under 510(k) number K190404.

Who is the listed applicant for OTIS Optical Coherence Tomography SYstem?

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

What is the FDA product code for OTIS Optical Coherence Tomography SYstem?

The FDA product code for OTIS Optical Coherence Tomography SYstem is NQQ.

Perimeter Medical Imaging, Inc.를 신청인으로 등재한 기타 기록

K171560오티스 광역도적성断层영상 시스템 K160240Perimeter Otis™ 1.0 광역도수측정 시스템

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