Carbon Dioxide Analyzer
by Corning Medical & Scientific
510(k) K771610
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK771610 | Date7 Oct 1977 | 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- Withdrawn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
- CIE
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1160
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
A Carbon Dioxide Analyzer is a volumetric/manometric device used for measuring carbon dioxide in medical applications. It is classified under Clinical Chemistry specialty and corresponds to regulation number 862.1160.
The device was submitted as a traditional 510(k) application (K771610) by Corning Medical & Scientific of Mchenry, Illinois, and received FDA clearance on October 7, 1977. It is supplied as a non-sterile, reusable medical device intended for use in clinical laboratory settings.
Other devices from Corning Medical & Scientific
Questions
AI-generated answers, 23 Sep 2026
What is the Carbon Dioxide Analyzer used for?
The Carbon Dioxide Analyzer is a volumetric/manometric device used for measuring carbon dioxide in medical applications, specifically within clinical laboratory settings as part of Clinical Chemistry specialty testing.
Is the Carbon Dioxide Analyzer sterile or non-sterile, and is it intended for single use or reuse?
The device is supplied as non-sterile and is designed for reuse, meaning it can be cleaned and used multiple times in a clinical laboratory environment after appropriate processing between uses.
How was the Carbon Dioxide Analyzer cleared for market, and what is its regulatory pathway?
The device received FDA clearance through a traditional 510(k) submission (K771610) on October 7, 1977, based on a determination of substantial equivalence to a legally marketed predicate device.