FDA 510(k)

C-IT

K-Number: K000520 · 2000-05-16

Decision Date2000-05-16

Product CodeCCK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

C-IT is the device name listed in this FDA 510(k) record. The listed applicant is Bregas AB. It received FDA 510(k) clearance on 2000-05-16 under 510(k) number K000520. 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 C-IT?

C-IT is a medical device that received FDA 510(k) clearance on 2000-05-16. The listed applicant is Bregas AB. The 510(k) number is K000520.

When did C-IT receive FDA 510(k) clearance?

C-IT received FDA 510(k) clearance on 2000-05-16, under 510(k) number K000520.

Who is the listed applicant for C-IT?

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 C-IT?

The FDA product code for C-IT 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.

K023820CO2 CLIP

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.