FDA 510(k)

CARESCAPE 呼吸模块，E-sCO，E-sCOV，E-sCOVX，E-sCAiO

K号: K183394 · 2019-05-01

决定日期2019-05-01

产品代码CCK

咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。

决定实质等同

器械摘要

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.

常见问题

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?

FDA 510(k)记录显示GE Healthcare Finland Oy为申请人。这本身并不能确立该设备的制造商。

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.

列明GE Healthcare Finland Oy为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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智能显示屏 K223531CARESCAPE Canvas 1000，CARESCAPE Canvas智能显示屏，CARESCAPE Canvas D19，F2框架（F2-01）K213336Carescape B850，E-musb K213181CARESCAPE B650，E-musb K213363CARESCAPE B450，E-musb

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官方来源

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