The following data is part of a premarket notification filed by Unimed Medical Supplies, Inc. with the FDA for Unimed Co2 Mainstream Module Model Capno-m, Unimed Co2 Mainstream Module Model Capno-m+.
| Device ID | K210019 |
| 510k Number | K210019 |
| Device Name: | Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+ |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | Unimed Medical Supplies, Inc. Bld#8, Nangang 3rd Industrial Park Tangtou, Shiyan Shenzhen, CN 518108 |
| Contact | Linbin Ye |
| Correspondent | Linbin Ye Unimed Medical Supplies, Inc. Bld#8, Nangang 3rd Industrial Park Tangtou, Shiyan Shenzhen, CN 518108 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-04 |
| Decision Date | 2021-03-04 |