FDA 510(k)

IntelliVue Capnography Extension, IntelliVue Microstream Extension

K-Number: K172904 · 2017-12-26

ApplicantPhilips Medizin Systeme Boeblingen GmbH

Decision Date2017-12-26

Product CodeCCK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

IntelliVue Capnography Extension, IntelliVue Microstream Extension is a medical device manufactured by Philips Medizin Systeme Boeblingen GmbH. It received FDA 510(k) clearance on 2017-12-26 under approval number K172904. 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 IntelliVue Capnography Extension, IntelliVue Microstream Extension?

IntelliVue Capnography Extension, IntelliVue Microstream Extension is a medical device that received FDA 510(k) clearance on 2017-12-26. It is manufactured by Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K172904.

When was IntelliVue Capnography Extension, IntelliVue Microstream Extension approved by the FDA?

IntelliVue Capnography Extension, IntelliVue Microstream Extension received FDA 510(k) clearance on 2017-12-26, under approval number K172904.

What company makes IntelliVue Capnography Extension, IntelliVue Microstream Extension?

IntelliVue Capnography Extension, IntelliVue Microstream Extension is manufactured by Philips Medizin Systeme Boeblingen GmbH.

What is the FDA product code for IntelliVue Capnography Extension, IntelliVue Microstream Extension?

The FDA product code for IntelliVue Capnography Extension, IntelliVue Microstream Extension is CCK.

Other Devices by Philips Medizin Systeme Boeblingen GmbH

K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800 K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable K161767Philips IntelliVue GuardianSoftware K181831IntelliVue Multi-Measurement Module MMX K173941IntelliSpace Perinatal Rev.K.00 K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension

View all 20 devices →

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 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. K161860TG-970P CO2 Sensor KitNihon Kohden Corporation

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.