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FDA 510(k)

CO2 Sampling Line

K-Number: K181981 · 2019-02-06

Decision Date2019-02-06
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CO2 Sampling Line is the device name listed in this FDA 510(k) record. The listed applicant is Tylenol Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2019-02-06 under 510(k) 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. The listed applicant is Tylenol Medical Instruments Co., Ltd.. The 510(k) number is K181981.

When did CO2 Sampling Line receive FDA 510(k) clearance?

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

Who is the listed applicant for CO2 Sampling Line?

The FDA 510(k) record lists Tylenol Medical Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CO2 Sampling Line?

The FDA product code for CO2 Sampling Line is CCK.

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.

Official Source

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