FDA 510(k)

CO2 CLIP

K-Number: K023820 · 2003-05-07

Decision Date2003-05-07

Product CodeCCK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

CO2 CLIP is the device name listed in this FDA 510(k) record. The listed applicant is Bregas AB. It received FDA 510(k) clearance on 2003-05-07 under 510(k) number K023820. 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 CO2 CLIP?

CO2 CLIP is a medical device that received FDA 510(k) clearance on 2003-05-07. The listed applicant is Bregas AB. The 510(k) number is K023820.

When did CO2 CLIP receive FDA 510(k) clearance?

CO2 CLIP received FDA 510(k) clearance on 2003-05-07, under 510(k) number K023820.

Who is the listed applicant for CO2 CLIP?

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

What is the FDA product code for CO2 CLIP?

The FDA product code for CO2 CLIP is CCK.

Other records listing Bregas AB 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.

K000520C-IT

Related Devices (Code: CCK)

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden Corporation K261633VisuBreathAffirm Medical Technologies II, LLC K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC K250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden Corporation K2512160184 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.