CO2 Content
510(k) K800111
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK800111 | Date13 Feb 1980 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CIL
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1160
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Co2 Content is a clinical chemistry device used for carbon-dioxide colorimetry, specifically utilizing Cresol Red Colorimetry. It is classified as a class 2 device. The device operates under the regulation number 862.1160.
The Co2 Content device is supplied by American Monitor Corp. and has been cleared under FDA 510K with the clearance number K800111. It is intended for use in clinical chemistry settings and is a single product code, CIL. The device was cleared on February 13, 1980.
Other devices from American Monitor Corp.
Questions
AI-generated answers, 25 Sep 2026
What is the CO2 Content device used for?
The CO2 Content device is used for carbon-dioxide colorimetry in clinical chemistry settings, utilizing Cresol Red Colorimetry.
Is the CO2 Content device cleared by the FDA?
Yes, the CO2 Content device has been cleared under FDA 510K with the clearance number K800111, indicating it is substantially equivalent to a predicate device.
What is the product code for the CO2 Content device?
The CO2 Content device has a single product code, CIL, which is used to identify it in clinical chemistry settings.