Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector— 510(k) K203762
Substantially EquivalentCovidien
FDA 510(k) clearance K203762 for Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector, Substantially Equivalent on 2021-09-17. Applicant: Covidien. Device class: 2.
Clearance details
- Applicant
- Covidien
- Product code
- Code CCK
- Device class
- Class 2
- Regulation
- 21 CFR 868.1400
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boulder, CO, US
Recent devices under product code CCK
view allMore clearances from Covidien
view all- K241486 — Sofsilk Coated Braided Silk Suture
- K240077 — Mon-a-Therm General Purpose Temperature Probe 400TM (90050, 90044)
- K231934 — GIA Stapler with Tri-Staple Technology
- K231240 — MaxTack Motorized Fixation Device
- K223130 — Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)
Adverse events under product code CCK
product code CCK- Death
- 3
- Malfunction
- 11,428
- Total
- 11,431
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.