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, No. 10, Xinhua Road, Sanjiao Town |
Zhong Shan,
CN
528445
|
|
Applicant Contact |
Kavin Huang |
Correspondent |
Tylenol Medical Instruments Co., Ltd |
3rd Floor, No. 10, Xinhua Road, Sanjiao Town |
Zhong Shan,
CN
528445
|
|
Correspondent Contact |
Kavin Huang |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 07/25/2018 |
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
|
|
|