The following data is part of a premarket notification filed by Tylenol Medical Instruments Co., Ltd with the FDA for Co2 Sampling Line.
| Device ID | K181981 |
| 510k Number | K181981 |
| Device Name: | CO2 Sampling Line |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | Tylenol Medical Instruments Co., Ltd 3rd Floor, No. 10, Xinhua Road, Sanjiao Town Zhong Shan, CN 528445 |
| Contact | Kavin Huang |
| Correspondent | Kavin Huang Tylenol Medical Instruments Co., Ltd 3rd Floor, No. 10, Xinhua Road, Sanjiao Town Zhong Shan, CN 528445 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-25 |
| Decision Date | 2019-02-06 |
| Summary: | summary |