The following data is part of a premarket notification filed by Covidien Llc with the FDA for Microstream Co2 Nanopod.
| Device ID | K213911 |
| 510k Number | K213911 |
| Device Name: | Microstream CO2 NanoPod |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | Covidien LLC 6135 Gunbarrel Ave Boulder, CO 80301 |
| Contact | Andrew Berkeland |
| Correspondent | Andrew Berkeland Covidien LLC 6135 Gunbarrel Ave Boulder, CO 80301 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-15 |
| Decision Date | 2022-07-29 |