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FDA 510(k)

CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR

K-Number: K112840 · 2012-07-13

ApplicantSeebreath AB
Decision Date2012-07-13
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Seebreath AB. It received FDA 510(k) clearance on 2012-07-13 under 510(k) number K112840. 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 CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR?

CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR is a medical device that received FDA 510(k) clearance on 2012-07-13. The listed applicant is Seebreath AB. The 510(k) number is K112840.

When did CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR receive FDA 510(k) clearance?

CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR received FDA 510(k) clearance on 2012-07-13, under 510(k) number K112840.

Who is the listed applicant for CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR?

The FDA 510(k) record lists Seebreath AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR?

The FDA product code for CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR is CCK.

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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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