Data / Medical devices / Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase (CCJ): 9 FDA-registered makers in 6 countries
9 establishments in 6 countries are registered with the FDA to make Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase (product code CCJ, Class 2, 21 CFR 868.1430). 7 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 28 510(k) clearances under this code, the latest on May 29, 2026, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- CCJ
- Device class
- 2
- Regulation
- 868.1430
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| United Kingdom | 2 |
| Germany | 1 |
| France | 1 |
| Ireland | 1 |
| Mexico | 1 |
Makers of Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bedfont Scientific Ltd. | MAIDSTONE Kent, United Kingdom | Manufacturer | 6 | December 21, 2021 | 0 | 0 | 0 | api.fda.gov |
| Capnia, Inc. | Foster City, CA, United States | Manufacturer | 3 | July 22, 2015 | 0 | 1 | 0 | api.fda.gov |
| Jaeger Medical GmbH | HOECHBERG Bavaria, Germany | Complaint file establishment, Manufacturer | 2 | October 17, 1996 | 0 | 0 | 0 | api.fda.gov |
| Fim Medical | Villeurbanne Cedex Rhone, France | Manufacturer | 1 | November 28, 2008 | 0 | 0 | 0 | api.fda.gov |
| MD Diagnostics Ltd | Chatham Kent, United Kingdom | Manufacturer | 1 | March 2, 2018 | 0 | 0 | 0 | api.fda.gov |
| Pivot Health Technologies Inc | San Carlos, CA, United States | Specification developer | 1 | September 29, 2017 | 0 | 0 | 0 | api.fda.gov |
| Vitalograph Ireland Ltd. | Co Clare, Ireland | Manufacturer | 1 | May 5, 1989 | 0 | 0 | 0 | api.fda.gov |
| Mossman Associates, Inc. | Milford, MA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Seacomp Displays | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 29, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.