The following data is part of a premarket notification filed by Orantech Inc. with the FDA for Etco2 Sensor.
| Device ID | K171828 |
| 510k Number | K171828 |
| Device Name: | ETCO2 Sensor |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | Orantech Inc. Zone#A,4F,1st Bld, 7th Industrial Zone Yulv Community, GongMing, Guangming Shenzhen, CN 518106 |
| Contact | Yunxi Xiong |
| Correspondent | Mei Mei Chonconn Medical Device Consulting Co.LTD. 22A,HaiJing Square,No.18 Taizi Road,Nanshan District, Shenzhen, CN 51800 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-20 |
| Decision Date | 2018-05-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970706360668 | K171828 | 000 |