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FDA 510(k)

Capnostream 35 Portable Respiratory Monitor

K-Number: K200594 · 2020-04-27

ApplicantOridion Medical 1987 , Ltd.
Decision Date2020-04-27
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Capnostream 35 Portable Respiratory Monitor is a medical device manufactured by Oridion Medical 1987 , Ltd.. It received FDA 510(k) clearance on 2020-04-27 under approval number K200594. 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 Capnostream 35 Portable Respiratory Monitor?

Capnostream 35 Portable Respiratory Monitor is a medical device that received FDA 510(k) clearance on 2020-04-27. It is manufactured by Oridion Medical 1987 , Ltd.. The 510(k) number is K200594.

When was Capnostream 35 Portable Respiratory Monitor approved by the FDA?

Capnostream 35 Portable Respiratory Monitor received FDA 510(k) clearance on 2020-04-27, under approval number K200594.

What company makes Capnostream 35 Portable Respiratory Monitor?

Capnostream 35 Portable Respiratory Monitor is manufactured by Oridion Medical 1987 , Ltd..

What is the FDA product code for Capnostream 35 Portable Respiratory Monitor?

The FDA product code for Capnostream 35 Portable Respiratory Monitor is CCK.

Related Clinical Trials

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Other Devices by Oridion Medical 1987 , Ltd.

K181624Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line K181467Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line

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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