Seebreath AB
SwedenFDA applicant, unverified FDA FEI 3009754460
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Seebreath AB makes
Seebreath AB manufactures CO₂ detectors, including the Capnodura Combi and Capnodura Pedi, designed for monitoring exhaled carbon dioxide levels in medical settings.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the US.
Catalogue
Capnodura Combi & Capnodura Pedi CO2 Detector Ref K112840
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3009754460
- Address
- Birger Jarlsgatan 2, Stockholm
Frequently asked questions
How many devices does Seebreath AB have in the registry?
The registry currently lists 1 device for Seebreath AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Seebreath AB's devices?
Among its 1 most recently registered device, Seebreath AB has devices listed in FDA 510(k) (1 device).
What risk classes do Seebreath AB's devices fall under?
Among its 1 most recently registered device, the classes recorded for Seebreath AB's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Seebreath AB in the registry?
The most recently registered devices listed for Seebreath AB include CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR.