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FDA 510(k)

CAPNOSTREAM20 WITH MICROMEDICO2 MODULE

K-Number: K094012 · 2010-05-12

ApplicantOridion Capnography, Inc.
Decision Date2010-05-12
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CAPNOSTREAM20 WITH MICROMEDICO2 MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Oridion Capnography, Inc.. It received FDA 510(k) clearance on 2010-05-12 under 510(k) number K094012. 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 CAPNOSTREAM20 WITH MICROMEDICO2 MODULE?

CAPNOSTREAM20 WITH MICROMEDICO2 MODULE is a medical device that received FDA 510(k) clearance on 2010-05-12. The listed applicant is Oridion Capnography, Inc.. The 510(k) number is K094012.

When did CAPNOSTREAM20 WITH MICROMEDICO2 MODULE receive FDA 510(k) clearance?

CAPNOSTREAM20 WITH MICROMEDICO2 MODULE received FDA 510(k) clearance on 2010-05-12, under 510(k) number K094012.

Who is the listed applicant for CAPNOSTREAM20 WITH MICROMEDICO2 MODULE?

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

What is the FDA product code for CAPNOSTREAM20 WITH MICROMEDICO2 MODULE?

The FDA product code for CAPNOSTREAM20 WITH MICROMEDICO2 MODULE 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.

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Other records listing Oridion Capnography, Inc. 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.

K101995CAPNOSTREAM 20P WITH MASIMO SPO2 BOARDK082268CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEXK072295CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWAREK060065CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR

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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