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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 the device name listed in this FDA 510(k) record. The listed applicant is Oridion Medical 1987 , Ltd.. It received FDA 510(k) clearance on 2020-04-27 under 510(k) 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. The listed applicant is Oridion Medical 1987 , Ltd.. The 510(k) number is K200594.

When did Capnostream 35 Portable Respiratory Monitor receive FDA 510(k) clearance?

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

Who is the listed applicant for Capnostream 35 Portable Respiratory Monitor?

The FDA 510(k) record lists Oridion Medical 1987 , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05452226Neuromuscular Electrical Stimulation in COPD/Community Acquired PneumoniaCOMPLETED

Other records listing Oridion Medical 1987 , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 LineK181467Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line

Related Devices (Code: CCK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden CorporationK261633VisuBreathAffirm Medical Technologies II, LLCK253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCK250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling lineBarbaras Development, 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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