FDA 510(k)

CO2 Sampling Line

K-Number: K181981 · 2019-02-06

ApplicantTylenol Medical Instruments Co., Ltd.

Decision Date2019-02-06

Product CodeCCK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

CO2 Sampling Line is a medical device manufactured by Tylenol Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2019-02-06 under approval number K181981. 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 Sampling Line?

CO2 Sampling Line is a medical device that received FDA 510(k) clearance on 2019-02-06. It is manufactured by Tylenol Medical Instruments Co., Ltd.. The 510(k) number is K181981.

When was CO2 Sampling Line approved by the FDA?

CO2 Sampling Line received FDA 510(k) clearance on 2019-02-06, under approval number K181981.

What company makes CO2 Sampling Line?

CO2 Sampling Line is manufactured by Tylenol Medical Instruments Co., Ltd..

What is the FDA product code for CO2 Sampling Line?

The FDA product code for CO2 Sampling Line is CCK.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.