Data / Medical devices / Finland / Bittium Biosignals Ltd.
Bittium Biosignals Ltd.: FDA-registered device maker in KUOPIO Pohjois-Savo, Finland, 1 510(k) clearance
Bittium Biosignals Ltd. is registered with the FDA (registration 1000425315) in KUOPIO Pohjois-Savo, Finland. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 8, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000425315
- Address
- Pioneerinkatu 6, KUOPIO Pohjois-Savo, Finland, 70800
- Owner or operator
- Bittium Biosignals Ltd. (9027486)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- June 27, 2018
- Registered through
- 2026
- Brand names listed
- Bittium Cardiac Explorer, Bittium Cardiac Navigator, Bittium Faros 180 waterproof, Bittium Faros 360 waterproof, Bittium MiniSnap Sensitive 1-CH ECG Electrode, Bittium OmegaSnap 1-CH Adapter, Bittium OmegaSnap 1-CH ECG Electrode, Bittium OmegaSnap 2-CH ECG Electrode and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Detector And Alarm, Arrhythmia | DSI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Electrocardiograph, Ambulatory, With Analysis Algorithm | MLO | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 8, 2018 | K182030 | Faros Mobile | MLO | Substantially Equivalent | Bittium Biosignals , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Electrocardiograph
- All makers of Transmitters And Receivers, Electrocardiograph, Telephone
- All makers of Electrocardiograph, Ambulatory, With Analysis Algorithm
- All makers of Detector And Alarm, Arrhythmia
Updated November 8, 2018. 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.