The following data is part of a premarket notification filed by Covidien with the FDA for Nellcor Easycap Ii Adult Colorimetric Co2 Detector, Nellcor Pedcicap Pediatric Colorimetric Co2 Detector.
| Device ID | K203762 |
| 510k Number | K203762 |
| Device Name: | Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | Covidien 6135 Gunbarrel Ave Boulder, CO 80301 |
| Contact | Ashley Johnston |
| Correspondent | Ashley Johnston Covidien 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 | 2020-12-23 |
| Decision Date | 2021-09-17 |