FDA device listing
Bittium MiniSnap Sensitive 1-CH ECG Electrode,Bittium OmegaSnap 1-CH Adapter,Bittium OmegaSnap 1-CH ECG…
FDA device listing 1219622731 · Bittium Biosignals Ltd.
Key facts
| Proprietary names | Bittium MiniSnap Sensitive 1-CH ECG Electrode,Bittium OmegaSnap 1-CH Adapter,Bittium OmegaSnap 1-CH ECG Electrode,Bittium OmegaSnap 2-CH ECG Electrode,Bittium OmegaSnap 3-CH ECG Electrode,Bittium OmegaSnap Multi-CH Adapter,BodyGuardian MINI Strip,Fast-Fix ECG Electrode |
|---|---|
| Owner/operator | Bittium Biosignals Ltd. |
| Owner/operator number | 9027486 |
| Product codes | DRX |
| Device names | DRX - Electrode, Electrocardiograph |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.2360 |
| Review panels | Cardiovascular |
| Registered establishments | Bittium Biosignals Ltd. |
| Establishment registrations | 1000425315 |
| FEI numbers | 1000425315 |
| Establishment operations | Complaint File Establishment, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database