FDA 510(k)

스파이 피 오픈 필드 핸드홀더 플루오레스센스 영상 시스템

K-번호: K162885 · 2017-01-11

결정일2017-01-11

제품 코드OWN

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

SPY Phi Open Field Handheld Fluorescence Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Novadaq Technologies, Inc.. It received FDA 510(k) clearance on 2017-01-11 under 510(k) number K162885. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the SPY Phi Open Field Handheld Fluorescence Imaging System?

SPY Phi Open Field Handheld Fluorescence Imaging System is a medical device that received FDA 510(k) clearance on 2017-01-11. The listed applicant is Novadaq Technologies, Inc.. The 510(k) number is K162885.

When did SPY Phi Open Field Handheld Fluorescence Imaging System receive FDA 510(k) clearance?

SPY Phi Open Field Handheld Fluorescence Imaging System received FDA 510(k) clearance on 2017-01-11, under 510(k) number K162885.

Who is the listed applicant for SPY Phi Open Field Handheld Fluorescence Imaging System?

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

What is the FDA product code for SPY Phi Open Field Handheld Fluorescence Imaging System?

The FDA product code for SPY Phi Open Field Handheld Fluorescence Imaging System is OWN.

Novadaq Technologies, Inc.를 신청인으로 등재한 기타 기록

K161792핀포인트 내시경 플루오레스센스 이미징 시스템 K150956핀포인트 내시경 플루오레스센스 이미징 시스템

공식 출처

FDA 데이터베이스에서 보기 →

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