FDA 510(k)

CARESCAPE 호흡 모듈, E-sCO, E-sCOV, E-sCOVX, E-sCAiO

K-번호: K183394 · 2019-05-01

결정일2019-05-01

제품 코드CCK

자문 위원회안내: 의료기기 규제 문서 번역 요청입니다. 회사명, 제품명, FDA, 510(k), PMA, NCT, PMID, 식별자 및 URL을 보존하여 번역하여 주세요. 정책: 의료규제-v1. [원문] AN [번역] 안내

결정Substantially Equivalent

기기 요약

CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare Finland Oy. It received FDA 510(k) clearance on 2019-05-01 under 510(k) number K183394. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO?

CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO is a medical device that received FDA 510(k) clearance on 2019-05-01. The listed applicant is GE Healthcare Finland Oy. The 510(k) number is K183394.

When did CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO receive FDA 510(k) clearance?

CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO received FDA 510(k) clearance on 2019-05-01, under 510(k) number K183394.

Who is the listed applicant for CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO?

The FDA 510(k) record lists GE Healthcare Finland Oy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO?

The FDA product code for CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO is CCK.

GE Healthcare Finland Oy를 신청인으로 등재한 기타 기록

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M K260343Carescape Canvas 1000; Carescape Canvas 스마트 디스플레이 K223531CARESCAPE Canvas 1000, CARESCAPE Canvas 스마트 디스플레이, CARESCAPE Canvas D19, F2 프레임 (F2-01)K213336Carescape B850, E-musb K213181CARESCAPE B650, E-musb K213363CARESCAPE B450, E-musb

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