CIEClass II
Volumetric/Manometric, Carbon-Dioxide
21 CFR 862.1160 / Clinical Chemistry
CIE is the FDA product code for Volumetric/Manometric, Carbon-Dioxide, a class II device type, regulated under 21 CFR 862.1160. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- CIE
- Device name
- Volumetric/Manometric, Carbon-Dioxide
- Regulation
- 21 CFR 862.1160
- Device class
- Class II
- Review panel
- Clinical Chemistry
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 7
- Ingested recalls
- 0
Clearances, product code CIE
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1980 | 1 |
| 1982 | 1 |
| 1983 | 1 |
| 1987 | 1 |
| 1988 | 1 |
| 1990 | 1 |
Applicants with the most clearances
Product code CIE| Applicant | Clearances |
|---|---|
| Hf Scientific, Inc. | 2 |
| American Research Products Co. | 1 |
| Corning Medical & Scientific | 1 |
| Instrumentation Laboratory Co. | 1 |
| James L. Geraci & Associates, Inc. | 1 |
| Miles Laboratories, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code CIE.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
