FDA 510(k)

CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO

K-Number: K183394 · 2019-05-01

Decision Date2019-05-01

Product CodeCCK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by GE Healthcare Finland Oy. The 510(k) number is K183394.

When was CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO approved by the FDA?

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

What company makes CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO?

CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO is manufactured by GE Healthcare Finland Oy.

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.

Other Devices by GE Healthcare Finland Oy

K171028CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories K191323Carescape B850 K191249CARESCAPE B450 K191322E-EEGX, N-EEGX K191149CARESCAPE B650 K211171CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories

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Related Devices (Code: CCK)

K162343Westmed Gas Sampling Cannula with O2 deliveryWestmed, Inc. K151421Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample LinesSalter Labs K172904IntelliVue Capnography Extension, IntelliVue Microstream ExtensionPhilips Medizin Systeme Boeblingen GmbH K171765Nihon Kohden CO2 MonitorNihon Kohden Corporation K171028CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessoriesGE Healthcare Finland Oy K161250OC-FLEX Flexible IntraOral CannulaVenture Therapeutics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.