Smart Solutions Technologies SL
SpainFDA applicant, unverified
- Devices
- 1
What Smart Solutions Technologies SL makes
Smart Solutions Technologies SL manufactures portable ECG recorders designed for ambulatory monitoring, as well as devices that detect and analyze cardiac arrhythmias. These products are intended for clinical use in identifying irregular heart rhythms and capturing continuous electrocardiogram data for diagnostic evaluation.
The company’s devices fall under FDA Class II regulation and are listed via the 510(k) clearance pathway. These products are registered with the U.S. Food and Drug Administration under the applicable regulatory framework for medical electrical equipment.
Catalogue
ECG recorder and Arrhythmia Detector Ref K173461
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 475359621
- [email protected]
- Phone
- +34678078697
Frequently asked questions
How many devices does Smart Solutions Technologies SL have in the registry?
The registry currently lists 1 device for Smart Solutions Technologies SL. Devices recorded under merged duplicate company entries are counted once.
Which registries list Smart Solutions Technologies SL's devices?
Among its 1 most recently registered device, Smart Solutions Technologies SL has devices listed in FDA 510(k) (1 device).
What risk classes do Smart Solutions Technologies SL's devices fall under?
Among its 1 most recently registered device, the classes recorded for Smart Solutions Technologies SL's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Smart Solutions Technologies SL in the registry?
The most recently registered devices listed for Smart Solutions Technologies SL include ECG recorder and Arrhythmia Detector.