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FDA 510(k)

EMMA Capnograph

K-Number: K201590 · 2021-03-29

ApplicantMasimo Corporation
Decision Date2021-03-29
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EMMA Capnograph is a medical device manufactured by Masimo Corporation. It received FDA 510(k) clearance on 2021-03-29 under approval number K201590. 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 EMMA Capnograph?

EMMA Capnograph is a medical device that received FDA 510(k) clearance on 2021-03-29. It is manufactured by Masimo Corporation. The 510(k) number is K201590.

When was EMMA Capnograph approved by the FDA?

EMMA Capnograph received FDA 510(k) clearance on 2021-03-29, under approval number K201590.

What company makes EMMA Capnograph?

EMMA Capnograph is manufactured by Masimo Corporation.

What is the FDA product code for EMMA Capnograph?

The FDA product code for EMMA Capnograph is CCK.

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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

View on FDA Database →

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

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