The following data is part of a premarket notification filed by Covidien Llc with the FDA for Carescape Co2 Microstream Parameter.
| Device ID | K213518 |
| 510k Number | K213518 |
| Device Name: | CARESCAPE CO2 Microstream Parameter |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | Covidien Llc 6135 Gunbarrel Ave Boulder, CO 80301 |
| Contact | Inna Reznikov |
| Correspondent | Inna Reznikov 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 | 2021-11-03 |
| Decision Date | 2022-04-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521799615 | K213518 | 000 |
| 10884521819023 | K213518 | 000 |
| 10884521815353 | K213518 | 000 |
| 10884521815346 | K213518 | 000 |