Karmelsonix
IsraelFDA applicant, unverified
- Devices
- 4
What Karmelsonix makes
Karmelsonix manufactures respiratory monitoring devices, including systems for continuous pulmonary function assessment like the Pulmotrack 2020 and Pulmotrack 5050 Wholter, which records data over extended periods. Their portfolio also includes portable diagnostic tools such as the Wim-PC Model 1010 for specific respiratory measurements and the Personal Wheezometer for assessing wheezing symptoms.
These devices fall under FDA Class II regulation and are authorised through the 510(k) clearance process. Karmelsonix is based in the United States, where its products are listed for commercial distribution.
Catalogue
Pulmotrack 2020 System Ref K102229
Regimes: 510(k) Registry: 510(k)Pulmotrack 5050 Wholter, Model 5050 Ref K101022
Regimes: 510(k) Registry: 510(k)Wim-Pc, Model 1010 Ref K071955
Regimes: 510(k) Registry: 510(k)Personal Wheezometer Ref K090863
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Karmelsonix have in the registry?
The registry currently lists 4 devices for Karmelsonix. Devices recorded under merged duplicate company entries are counted once.
Which registries list Karmelsonix's devices?
Among its 4 most recently registered devices, Karmelsonix has devices listed in FDA 510(k) (4 devices).
What risk classes do Karmelsonix's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Karmelsonix's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Karmelsonix in the registry?
The most recently registered devices listed for Karmelsonix include PULMOTRACK 2020 SYSTEM, PULMOTRACK 5050 WHOLTER, MODEL 5050, WIM-PC, MODEL 1010 and PERSONAL WHEEZOMETER.