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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K181981
Device Name CO2 Sampling Line
Applicant
Tylenol Medical Instruments Co., Ltd.
3rd Floor, # 10, Xinhua Rd., Sanjiao Town
Zhong Shan,  CN 528445
Applicant Contact Kavin Huang
Correspondent
Tylenol Medical Instruments Co., Ltd.
3rd Floor, # 10, Xinhua Rd., Sanjiao Town
Zhong Shan,  CN 528445
Correspondent Contact Kavin Huang
Regulation Number868.1400
Classification Product Code
CCK  
Date Received07/25/2018
Decision Date 02/06/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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